FallPhase 1/2NCT07852650
Digital STEADI Efficacy
A Phase 1/2 study testing Digital STEADI-1 and Digital STEADI-2 in people with Fall and Mild Cognitive Impairment (MCI), run by Friendi.fi Corporation at 1 site in United States.
Trial summary
The aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older adults, especially in those with Mild Cognitive Impairment (MCI), a precursor of Alzheimer's… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Mild Cognitive Impairment (MCI), Aging
- What is being tested?
- Digital STEADI-1 and Digital STEADI-2
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2026to May 2028
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) score between 26 and 30
- Able to walk independently with or without an assistive device.
- Able to rise independently from a standard desk or dining room chair without arms.
- Live independently in a non-institutional or senior community setting.
- Able to speak, hear and understand English
- Have 20/40 vision from 10 ft with or without correction (e.g., glasses)
Show all 9Show fewer
- Willing to participate in the requirements of the research program.
- Able to meet in a physical study location on Emory campus.
- Screen positive for fall risk per the Stay Independent screener.
Who cannot join
- acute medical illness requiring hospitalization.
- hospitalized in the past 1 month.
- diagnosed with dementia (ADRD) or a neurodegenerative disease other than MCI (e.g., Parkinson's, multiple sclerosis).
- uncontrolled congestive heart failure (requiring hospitalization in the past year and/or unable to the equivalent of one city block).
- history of hospitalization for stroke in the past 1 year.
- inability to perform study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cheri Maggard, M.A. contact
United States1 site, 1 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30329
About this study
Official title: Randomized Control Trial to Test the Efficacy of the Digital STEADI Program.
The aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older adults, especially in those with Mild Cognitive Impairment (MCI), a precursor of Alzheimer's dementia (AD) and related dementias (ADRD). There is an urgent need for scalable, evidence-based interventions that can be delivered efficiently in the home setting. This study aims to evaluate the efficacy and impact of a comprehensive digital fall prevention program (Digital STEADI) delivered through a technology platform with two conversational agents that leverage generative artificial intelligence (gen-AI) with human oversight to increase program access, enhance adherence to clinical fall prevention protocols and best practices, and reduce fall risk among community-dwelling older adults.
Read the detailed description
The Centers for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths \& Injuries (STEADI) Initiative integrates fall risk screening, assessment, and intervention according to established clinical guidelines from the American and British Geriatrics Societies. Although STEADI is a proven multifactorial intervention, traditional dissemination models relying on in-person visits, paper-based materials, and intensive human monitoring and care coordination present significant barriers to widespread implementation for impact at the population level.
The sponsor in collaboration with clinical and academic partners, will test a digital STEADI intervention program incorporating an evidence-based exercise program (Otago, OEP) to provide strength and balance training and continuous coaching. The digital program is implemented via two conversational agents, a tablet-based avatar or mobile chat via SMS, supported by gen-AI and trained human staff who supervise the agents as needed. Both agents provide 24x7 companionship with protocolized health coaching and escalation to care providers as needed. The technology has been rigorously validated in cognitively normal (CN) as well as frail older adults with multiple chronic conditions including serious mental illness (SMI), MCI and ADRD. It is optimized for ongoing fall risk monitoring, personalized exercise prescription, and coordinated care. The full digital STEADI program was successfully tested for feasibility and safety in two pilot studies with older adults with and without MCI, one in a simulated home environment and another in private homes of community-dwelling older adults. Upon the successful completion of the randomized control trial (RCT), the Digital STEADI program will be prepared for national implementation and commercialization.
A randomized control trial (RCT, N= 300) will be conducted to evaluate the efficacy of the digital STEADI program including OEP compared to standard STEADI (STEADI-Standard) and attentional control (STEADI-Control) conditions. A subset of participants with MCI will be assigned to the STEADI-Avatar group to evaluate the digital program in this high-risk population. All participants will be community-dwelling older adults aged ≥50 years at risk for falls.
- Conditions
- Fall, Mild Cognitive Impairment (MCI), Aging
- Being tested
- Digital STEADI-1, STEADI Standard of Care, Digital STEADI-2, Attentional control
- Keywords
- fall prevention, older adults, artificial intelligence, conversational agents, chatbot, avatar
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital STEADI-1Behavioural
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
STEADI Standard of CareBehavioural
STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
Digital STEADI-2Behavioural
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
Attentional controlBehavioural
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.
| Study group | Role | What they receive |
|---|---|---|
| STEADI-Avatar | Experimental | Cognitively normal participants receiving the intervention via technology. Receives: Behavioral: Digital STEADI-1 |
| STEADI-Chat | Experimental | Cognitively normal participants receiving the intervention via technology. Receives: Behavioral: Digital STEADI-2 |
| STEADI-Standard | Active comparator | Cognitively normal participants receiving the intervention via traditional, non-technological means. Receives: Behavioral: STEADI Standard of Care |
| STEADI-Control | Sham comparator | Cognitively normal participants receiving an intervention via traditional, non-technological means. Receives: Behavioral: Attentional control |
| STEADI MCI | Experimental | Participants with mild cognitive impairment receiving the intervention via technology. Receives: Behavioral: Digital STEADI-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
Scores will vary between 16 and 64 for the full scale. Scores between 16-19 indicate fear of falling is LOW. Scores between 20-27 indicate fear of falling is MODERATE. Scores between 28-64 indicate fear of falling is HIGH.
Measured: From enrollment to the end of the follow-up at 6 months.
Secondary outcomes (1)
Cumulative, recurrent number of falls during the 6-month intervention period.
Participants will report fall status weekly and achieve a response if they report falling in the week preceding the report.
Measured: From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start4 Sep 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friendi.fi Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chantal Kerssens, MSc, PhD, Study director, Friendi.fi CorporationMadeleine E Hackney, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852650
- Sponsor's protocol ID
- R44AG085913_RCT
- Other IDs
- R44AG085913
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Test the Efficacy of the Digital STEADI Program.
- ClinicalTrials.gov ID
- NCT07852650
- Acronym / sponsor ID
- R44AG085913_RCT
- Conditions
- Fall, Mild Cognitive Impairment (MCI), Aging
- Keywords
- fall prevention, older adults, artificial intelligence, conversational agents, chatbot, avatar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Friendi.fi CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Emory University, National Institute on Aging (NIA)
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Oct 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 aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older adults, especially in those with Mild Cognitive Impairment (MCI), a precursor of Alzheimer's dementia (AD) and related dementias (ADRD). There is an urgent need for scalable, evidence-based interventions that can be delivered efficiently in the home setting. This study aims to evaluate the efficacy and impact of a comprehensive digital fall prevention program (Digital STEADI) delivered through a technology platform with two conversational agents that leverage generative artificial intelligence (gen-AI) with human oversight to increase program access, enhance adherence to clinical fall prevention protocols and best practices, and reduce fall risk among community-dwelling older adults.
Detailed description
The Centers for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths \& Injuries (STEADI) Initiative integrates fall risk screening, assessment, and intervention according to established clinical guidelines from the American and British Geriatrics Societies. Although STEADI is a proven multifactorial intervention, traditional dissemination models relying on in-person visits, paper-based materials, and intensive human monitoring and care coordination present significant barriers to widespread implementation for impact at the population level.
The sponsor in collaboration with clinical and academic partners, will test a digital STEADI intervention program incorporating an evidence-based exercise program (Otago, OEP) to provide strength and balance training and continuous coaching. The digital program is implemented via two conversational agents, a tablet-based avatar or mobile chat via SMS, supported by gen-AI and trained human staff who supervise the agents as needed. Both agents provide 24x7 companionship with protocolized health coaching and escalation to care providers as needed. The technology has been rigorously validated in cognitively normal (CN) as well as frail older adults with multiple chronic conditions including serious mental illness (SMI), MCI and ADRD. It is optimized for ongoing fall risk monitoring, personalized exercise prescription, and coordinated care. The full digital STEADI program was successfully tested for feasibility and safety in two pilot studies with older adults with and without MCI, one in a simulated home environment and another in private homes of community-dwelling older adults. Upon the successful completion of the randomized control trial (RCT), the Digital STEADI program will be prepared for national implementation and commercialization.
A randomized control trial (RCT, N= 300) will be conducted to evaluate the efficacy of the digital STEADI program including OEP compared to standard STEADI (STEADI-Standard) and attentional control (STEADI-Control) conditions. A subset of participants with MCI will be assigned to the STEADI-Avatar group to evaluate the digital program in this high-risk population. All participants will be community-dwelling older adults aged ≥50 years at risk for falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| STEADI-Avatar | Experimental | Behavioral: Digital STEADI-1Cognitively normal participants receiving the intervention via technology. |
| STEADI-Chat | Experimental | Behavioral: Digital STEADI-2Cognitively normal participants receiving the intervention via technology. |
| STEADI-Standard | Active comparator | Behavioral: STEADI Standard of CareCognitively normal participants receiving the intervention via traditional, non-technological means. |
| STEADI-Control | Sham comparator | Behavioral: Attentional controlCognitively normal participants receiving an intervention via traditional, non-technological means. |
| STEADI MCI | Experimental | Behavioral: Digital STEADI-1Participants with mild cognitive impairment receiving the intervention via technology. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Montreal Cognitive Assessment (MoCA) score between 26 and 30
- Able to walk independently with or without an assistive device.
- Able to rise independently from a standard desk or dining room chair without arms.
- Live independently in a non-institutional or senior community setting.
- Able to speak, hear and understand English
Key exclusion criteria (6 listed)
- acute medical illness requiring hospitalization.
- hospitalized in the past 1 month.
- diagnosed with dementia (ADRD) or a neurodegenerative disease other than MCI (e.g., Parkinson's, multiple sclerosis).
- uncontrolled congestive heart failure (requiring hospitalization in the past year and/or unable to the equivalent of one city block).
- history of hospitalization for stroke in the past 1 year.
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 |
|---|---|---|
| Digital STEADI-1STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar. | Behavioural | STEADI MCI, STEADI-Avatar |
| STEADI Standard of CareSTEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans. | Behavioural | STEADI-Standard |
| Digital STEADI-2STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat. | Behavioural | STEADI-Chat |
| Attentional controlReceiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care. | Behavioural | STEADI-Control |
Primary outcome
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
Time frame: From enrollment to the end of the follow-up at 6 months.
Scores will vary between 16 and 64 for the full scale. Scores between 16-19 indicate fear of falling is LOW. Scores between 20-27 indicate fear of falling is MODERATE. Scores between 28-64 indicate fear of falling is HIGH.
1 secondary outcome
Cumulative, recurrent number of falls during the 6-month intervention period.
Time frame: From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.
Related trials for Fall
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Recruiting
Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation
Deep Brain Stimulation, PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
Myeloid Chimerism
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
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.
Cheri Maggard, M.A. contact
Chantal Kerssens, MSc, PhD study director
Friendi.fi Corporation
Madeleine E Hackney, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Digital STEADI-1 and Digital STEADI-2 in people with Fall and Mild Cognitive Impairment (MCI), run by Friendi.fi Corporation at 1 site in United States.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chantal Kerssens, MSc, PhD (404-282-0378, chantal@friendi.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I) (time frame: From enrollment to the end of the follow-up at 6 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 1 Oct 2026.