FallAL-STEADINCT07531641
From Screening to Safety: Implementing the AL-STEADI Initiative in Assisted Living Communities
A study testing AL-STEADI in people with Fall and Fall Injury Prevention, run by Brown University.
Trial summary
The goal of this trial is to test the real-world efficacy of AL-STEADI, a fall prevention program, in participating assisted living centers. The investigators will randomly assign residents from participating assisted living centers who screen at-risk of falling to either existing fall monitoring protocols or the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall, Fall Injury Prevention, Fall Prevention
- What is being tested?
- AL-STEADI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in participating assisted living communities
Who cannot join
- Not living in participating assisted living communities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this trial is to test the real-world efficacy of AL-STEADI, a fall prevention program, in participating assisted living centers. The investigators will randomly assign residents from participating assisted living centers who screen at-risk of falling to either existing fall monitoring protocols or the enhanced AL-STEADI fall prevention program. The investigators will evaluate the effect of AL-STEADI on the rate of falls over 12 months. The investigators will also closely monitor implementation fidelity in these participating assisted living centers.
- Conditions
- Fall, Fall Injury Prevention, Fall Prevention
- Being tested
- AL-STEADI, Usual Care Group
- Keywords
- assisted living, fall prevention, STEADI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-STEADIBehavioural
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.
Usual Care GroupBehavioural
Typical fall prevention practices, including increased monitoring by assisted living staff
| Study group | Role | What they receive |
|---|---|---|
| AL-STEADI | Experimental | Not described Receives: Behavioral: AL-STEADI |
| Existing fall monitoring protocols | Active comparator | Not described Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate
Number of staff documented falls per 12 non-censored person-months, among individuals who screen at-risk for falls
Measured: 12 person-months
Secondary outcomes (9)
Proportion of fall-risk residents with any fall
Proportion of residents with any staff documented fall during follow-up, among individuals who screen at-risk for falls
Measured: 12 person-months
Injurious fall rate among fall-risk residents
Number of staff documented injurious falls per 12 non-censored person-months, among individuals who screen at-risk for falls
Measured: 12 person-months
Proportion of fall-risk residents with any injurious fall
Proportion of residents with any staff documented injurious fall during follow-up, among individuals who screen at-risk for falls
Measured: 12 person-months
Hospital transfer rate among fall-risk residents
Number of hospital transfers per 12 non-censored person-months, among individuals who screen at-risk for falls
Measured: 12 person-months
Proportion of fall-risk residents with any hospital transfer
Proportion of residents with any hospital transfers during follow-up, among individuals who screen at-risk for falls
Measured: 12 person-months
Hospitalization rate among fall-risk residents
Number of in-patient hospitalizations per 12 non-censored person-months, among individuals who screen at-risk for falls
Measured: 12 person-months
Proportion of fall-risk residents with any hospitalization
Proportion of residents with any in-patient hospitalization during follow-up, among individuals who screen at-risk for falls
Measured: 12 person-months
Skilled nursing stay rate among fall-risk residents
Number of skilled nursing stays per 12 non-censored person-months, among individuals who screen at-risk for falls
Measured: 12 person-months
Proportion of fall-risk residents with any skilled nursing stay
Proportion of residents with any skilled nursing stay during follow-up, among individuals who screen at-risk for falls
Measured: 12 person-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531641
- Sponsor's protocol ID
- U01CE003720
- Other IDs
- U01CE003720
- Acronym
- AL-STEADI
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Screening to Safety: Implementing the AL-STEADI Initiative in Assisted Living Communities
- ClinicalTrials.gov ID
- NCT07531641
- Acronym / sponsor ID
- AL-STEADI / U01CE003720
- Conditions
- Fall, Fall Injury Prevention, Fall Prevention
- Keywords
- assisted living, fall prevention, STEADI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to test the real-world efficacy of AL-STEADI, a fall prevention program, in participating assisted living centers. The investigators will randomly assign residents from participating assisted living centers who screen at-risk of falling to either existing fall monitoring protocols or the enhanced AL-STEADI fall prevention program. The investigators will evaluate the effect of AL-STEADI on the rate of falls over 12 months. The investigators will also closely monitor implementation fidelity in these participating assisted living centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-STEADI | Experimental | Behavioral: AL-STEADI |
| Existing fall monitoring protocols | Active comparator | Behavioral: Usual Care Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living in participating assisted living communities
Key exclusion criteria (1 listed)
- Not living in participating assisted living communities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL-STEADISTEADI 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. | Behavioural | AL-STEADI |
| Usual Care GroupTypical fall prevention practices, including increased monitoring by assisted living staff | Behavioural | Existing fall monitoring protocols |
Primary outcome
Fall rate
Time frame: 12 person-months
Number of staff documented falls per 12 non-censored person-months, among individuals who screen at-risk for falls
9 secondary outcomes
Proportion of fall-risk residents with any fall
Time frame: 12 person-months
Injurious fall rate among fall-risk residents
Time frame: 12 person-months
Proportion of fall-risk residents with any injurious fall
Time frame: 12 person-months
Hospital transfer rate among fall-risk residents
Time frame: 12 person-months
Proportion of fall-risk residents with any hospital transfer
Time frame: 12 person-months
Hospitalization rate among fall-risk residents
Time frame: 12 person-months
Proportion of fall-risk residents with any hospitalization
Time frame: 12 person-months
Skilled nursing stay rate among fall-risk residents
Time frame: 12 person-months
Proportion of fall-risk residents with any skilled nursing stay
Time frame: 12 person-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AL-STEADI in people with Fall and Fall Injury Prevention, run by Brown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen McCreedy, PhD, MPH ((401) 863-7345, ellen_mccreedy@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall rate (time frame: 12 person-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.