Multiple Sclerosis Falls Insight Track

NCT05837949 | Active Not Recruiting DMC

• 2 other identifiers: 22-366805R01LM013396-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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

  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.

  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

  12 months

Study Arms (1)

MS FIT: Falls Insight Track

EXPERIMENTAL

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

Behavioral: MS FIT: Falls Insight Track

Interventions

MS FIT: Falls Insight Track BEHAVIORAL

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

MS FIT: Falls Insight Track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• National Library of Medicine (NLM): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• 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.

  PMID: 38206662 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be given the MS FIT tool intervention

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: April 12, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months post trial
• Access Criteria: Qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement

Locations

US (1)