NCT07531641

Brief Summary

The goal of this trial is to test the real-world efficacy of AL-STEADI, a fall prevention program, in seven assisted living centers. We will randomly assign 700 residents from seven assisted living centers who screen at-risk of falling to either existing fall monitoring protocols or the enhanced AL-STEADI fall prevention program. We will evaluate the effect of AL-STEADI on the rate of falls over 12 months. We will also closely monitor implementation fidelity in these seven assisted living centers.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jun 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

assisted livingfall preventionSTEADI

Outcome Measures

Primary Outcomes (1)

  • Fall rate

    Number of staff documented falls per 12 non-censored person-months, among individuals who screen at-risk for falls

    12 person-months

Study Arms (2)

AL-STEADI

EXPERIMENTAL
Behavioral: AL-STEADI

Existing fall monitoring protocols

ACTIVE COMPARATOR
Behavioral: Usual Care Group

Interventions

AL-STEADIBEHAVIORAL

STEADI is an evidence-based falls prevention program developed by the CDC and tested in several community-based settings. STEADI involves universal fall screening, followed by personalized assessments and tailored interventions. Common, potentially modifiable causes of falls evaluated in STEADI include medication interactions or side effects, environmental hazards (e.g., floor rugs, thresholds), untreated visual impairment, low vitamin D, ill-fitting footwear, or low blood pressure. AL-STEADI is a modified version of STEADI for assisted living.

AL-STEADI

Typical fall prevention practices, including increased monitoring by assisted living staff

Existing fall monitoring protocols

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ellen McCreedy, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Resident-level, electronic medical record data will be protected by Data Use Agreements and cannot be shared publicly. Summary tables may be made available; small cell restrictions and other measures to prevent re-identification would apply