CompletedNot Applicable

Electronic Strategies for Tailored Exercise to Prevent FallS

United States11,945 participantsStarted 2023-06-08

Plain-language summary

The objectives of this proposal are to evaluate the eSTEPS CDS (eSTEPS) in a cluster randomized controlled trial. The intervention includes the following: 1) A machine learning-based fall injury risk screening algorithm to improve traditional fall risk screening. 2) Provider BPA and/or Care Gap and Smart Set to provide CDS that helps primary care providers develop a tailored fall prevention exercise plan in the context of a Medicare Wellness Visit and 3) eSTEPS Patient App and exercise tools to provide older patients continued access to their interactive, tailored exercise plan.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Age 65 or above * Patients enrolled in participating primary care intervention and control practices at MGB or enrolled in participating primary care replication trial intervention practices at UTMB * Positive screen for fall risk at annual wellness visit Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: \- Not community-dwelling (i.e. residents of long-term care facilities, prisoners etc.) Enrollment in the Subsample for Patient Reported Outcomes (PROs): A subsample of patients will be recruited and consented to participate in follow-up phone calls and surveys. Additional exclusion criteria for the subsample participants are: * Unwilling or unable to provide verbal consent * Not able to participate due to cognitive impairment (i.e., 4 or more errors on the Callahan Cognitive Screen assessment) * Has a terminal illness or other condition that indicates that the participant is not expected to survive for 1 year, such as receiving hospice or palliative care services. * Not fluent in spoken English * Does not have access to a working telephone

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To Determine the Effect of the eSTEPS Intervention on the Rate of Falls

Timeframe: Up to 23 months

Trial details

NCT IDNCT04993781

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-08

Results submitted2026-05-08

View on ClinicalTrials.gov More Falls trials