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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Multiple Sclerosis Falls Insight Track

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05837949
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Riley Bove, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: MS FIT: Falls Insight Track

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

Interventions

Behavioral: - MS FIT: Falls Insight Track

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94158

Site Contact

Riley Bove, MD

[email protected]

415-595-2795

Nearest Location

Site Contact

Riley Bove, MD

[email protected]

415-595-2795


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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