Digital STEADI Efficacy
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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Chantal Kerssens, MSc, PhD
- Telefonnummer: 404-282-0378
- E-mail: chantal@friendi.fi
Undersøgelse Kontakt Backup
- Navn: Cheri Maggard, M.A.
- E-mail: cheri@friendi.fi
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Rekruttering
- Emory University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: STEADI-Avatar
Cognitively normal participants receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar. |
|
Eksperimentel: STEADI-Chat
Cognitively normal participants receiving the intervention via technology. |
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. |
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. |
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care. |
|
Eksperimentel: STEADI MCI
Participants with mild cognitive impairment receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
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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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Chantal Kerssens, MSc, PhD, Friendi.fi Corporation
- Ledende efterforsker: Madeleine E Hackney, PhD, Emory University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R44AG085913_RCT
- R44AG085913 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.
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