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Active, not recruitingNCT05837949MS FITUpdated Aug 11, 2026

Multiple Sclerosis Falls Insight Track

An interventional study of MS FIT: Falls Insight Track in Multiple Sclerosis, sponsored by University of California, San Francisco. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Multiple Sclerosis
  • MS
  • Falls
  • Falling
  • Closed-loop
  • Digital health
  • Falls tracking
  • Falls prevention
  • FitBit
  • Wearables
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    MS FIT: Falls Insight Track

    Participants in this arm will receive 12 months use of MS FIT mobile tool intervention

    Behavioral: MS FIT: Falls Insight Track

Interventions

  • BehavioralMS FIT: Falls Insight Track

    Participants will respond to a set of surveys every two weeks to increase communication on falls with their clinician.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. 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

    Time frame: 12 months

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94158, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05837949
Lead sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH), National Library of Medicine (NLM)
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Apr 12, 2023
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Aug 11, 2026

Study contacts

Riley Bove, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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