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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前：Chantal Kerssens, MSc, PhD
- 電話番号：404-282-0378
- メール：chantal@friendi.fi
研究連絡先のバックアップ
- 名前：Cheri Maggard, M.A.
- メール：cheri@friendi.fi
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30329
- 募集
- Emory University School of Medicine
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：STEADI-Chat
Cognitively normal participants receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat. |
|
アクティブコンパレータ：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. |
|
偽コンパレータ：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative, recurrent number of falls during the 6-month intervention period.
時間枠：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
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター：Chantal Kerssens, MSc, PhD、Friendi.fi Corporation
- 主任研究者：Madeleine E Hackney, PhD、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- R44AG085913_RCT
- R44AG085913 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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