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Digital STEADI Efficacy

25. september 2026 oppdatert av: Friendi.fi Corporation

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • Rekruttering
        • Emory University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: STEADI-Avatar

Cognitively normal participants receiving the intervention via technology.
Atferdsmessig: Digital STEADI-1

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
Eksperimentell: STEADI-Chat

Cognitively normal participants receiving the intervention via technology.
Atferdsmessig: Digital STEADI-2

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
Aktiv komparator: STEADI-Standard

Cognitively normal participants receiving the intervention via traditional, non-technological means.
Atferdsmessig: STEADI Standard of Care

STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
Sham-komparator: STEADI-Control

Cognitively normal participants receiving an intervention via traditional, non-technological means.
Atferdsmessig: Attentional control

Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.
Eksperimentell: STEADI MCI

Participants with mild cognitive impairment receiving the intervention via technology.
Atferdsmessig: Digital STEADI-1

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
Tidsramme: 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.
From enrollment to the end of the follow-up at 6 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cumulative, recurrent number of falls during the 6-month intervention period.
Tidsramme: From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death

Participants will report fall status weekly and achieve a response if they report falling in the week preceding the report.
From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Friendi.fi Corporation

Samarbeidspartnere

Emory University
National Institute on Aging (NIA)

Etterforskere

  • Studieleder: Chantal Kerssens, MSc, PhD, Friendi.fi Corporation
  • Hovedetterforsker: Madeleine E Hackney, PhD, Emory University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. september 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

25. september 2026

Først innsendt som oppfylte QC-kriteriene

25. september 2026

Først lagt ut (Faktiske)

1. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R44AG085913_RCT
  • R44AG085913 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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