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Digital STEADI Efficacy

2026年9月25日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

300

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Chantal Kerssens, MSc, PhD
  • 电话号码:404-282-0378
  • 邮箱:chantal@friendi.fi

研究联系人备份

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30329
        • 招聘中
        • Emory University School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

实验性的:STEADI-Chat

Cognitively normal participants receiving the intervention via technology.

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.

有源比较器: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.

假比较器: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.

实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Cumulative, recurrent number of falls during the 6-month intervention period.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Chantal Kerssens, MSc, PhD、Friendi.fi Corporation
  • 首席研究员:Madeleine E Hackney, PhD、Emory University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月4日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年9月25日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • R44AG085913_RCT
  • R44AG085913 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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