Preventing Medication Mismanagement in People Living With Dementia
2026年5月18日 更新者：HiDO Technologies
Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation
The purpose of this research is to learn whether the HiDO-ALZ device can improve medication compliance and health outcomes in participants with dementia that need to take daily medication.
調査の概要
詳細な説明
The Phase II SBIR goal is to enhance, validate, & commercialize HiDO-ALZ, an automated, secure, artificial intelligence (AI) driven medication delivery & observation platform to maximize therapy compliance & health outcomes in dementia.
Dementia and Alzheimer's disease (AD) negatively impact medication management.
The development of novel AI technology to improve independent patient adherence to complex medication schedules and remote reporting of compliance metrics to caregivers & providers would significantly optimize patient care and reduce healthcare costs.
The aim of this project is to test the functionality of the HiDO-ALZ technology in participants with dementia or symptoms of dementia as determined by current cognitive function.
An additional goal of this study is to determine the adherence rates and efficiency of the system in this population.
The hypothesis is that participants with dementia will have better medication compliance as compared to baseline prior to the implementation of the technology, and better than that of the control group.
The HiDO-ALZ platform will solve these challenges by automating medication administration for people with dementia (PwD) to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place.
HiDO-ALZ is an automated, AI driven medication dispensing and direct observation platform to optimize medication adherence.
The device integrates medication dispensing, dose administration time, medication synchronization, and a pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's).
Cameras record every dose using facial recognition & provide real-time medication consumption recordings.
Through cloud connectivity, caregivers have access to video observation logs, dose administration time, adherence trends, and longitudinal adherence via web dashboard.
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Charles Gellman
- 電話番号：510-813-7224
- メール：charles@hidohealth.com
研究場所
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California
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Folsom、California、アメリカ、95762
- 募集
- HiDO Technologies
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コンタクト：
- Charles Gellman
- 電話番号：5138137224
- メール：charles@hidohealth.com
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コンタクト：
- Lisa Marceau
- 電話番号：4014284197
- メール：lmarceau@alphamhealth.com
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主任研究者：
- Charles Gellman
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Participants must have a diagnosis of dementia.
- They must be prescribed one medication indicated for dementia symptoms such as Aricept, Namenda, or Donepezil, and be prescribed at least one additional medication.
- Participants must have an active study partner that is willing to be enrolled into the study and willing to receive messages and alerts from the HiDO-ALZ system if medications are missed. The study partner must also agree to complete surveys about the participant's ongoing health.
- Participants must be willing to allow research staff to enter their homes to install the HiDO-ALZ device and to complete study activities.
The participant's medications will be reviewed by the UCD pharmacist prior to randomization. If a participant has contraindicated medication(s), this medication will need to be removed or justified by the prescribing clinician prior to randomization. The research team and HiDO staff will work with the UCD pharmacist and prescribing clinician to resolve contraindicated medications prior to randomization. If a resolution is not possible, the participant will not be enrolled.
•MoCA score of 15 to 22 or previous MMSE score of 21 to 26 within the last 6 months.
If no test is available, the participants will be given a MoCA test after signing consent to confirm eligibility.
Exclusion Criteria
- The inability to demonstrate capacity to consent or assent as determined by the Capacity Assessment Checklist.
- Individuals who do not have a study partner/caregiver (e.g., spouse, adult child) to complete questionnaires.
- Participants with MoCA scores below 15 will be excluded as they may not be able to use the device independently.
- Participants who are unable or unwilling to complete the cognitive testing or unwilling to complete the blood tests.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：HiDO HomeCare System
The HiDO HomeCare System (HCS) is a medication dispensation device that participants will interface with via face recognition at the time they are expected to take medication.
HCS is tool that can assist participants and their care partners remember and monitor medication dosing.
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Participants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.
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介入なし：Standard Medication Management
Participants randomized to Standard Medication Management will continue taking medication as usual, without the assitance of the HiDO HCS.
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この研究は何を測定していますか？
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 to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
時間枠：baseline and 12-months
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The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a standardized assessment used to evaluate the severity of cognitive dysfunction.
The total score is derived from multiple cognitive domains, including memory, language, praxis, and orientation.
Change from baseline to the specified assessment timepoint will be analyzed, with higher scores indicating greater cognitive impairment.
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baseline and 12-months
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Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score
時間枠：Baesline, 4, 8, and 12 month timepoints
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Everyday Cognition (ECog) is a validated questionnaire used to assess cognitively relevant functional abilities in older adults across multiple domains.
The ECog total score will be calculated based on participant responses, with higher scores indicating greater perceived cognitive decline.
Change from baseline to the specified assessment timepoint will be analyzed.
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Baesline, 4, 8, and 12 month timepoints
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月5日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月18日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 5R44AG077737-03 (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?
はい
IPD プランの説明
Access will be limited to the study team, approved development personnel at HiDO Technologies, and affiliated clinical researchers involved in the design and analysis of future studies.
No third-party or external access will be granted without appropriate IRB review.
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
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HiDO HomeCareSystemの臨床試験
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HiDO TechnologiesRush University Medical Center積極的、募集していない