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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
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：Charles Gellman
- 电话号码：510-813-7224
- 邮箱：charles@hidohealth.com
学习地点
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California
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Folsom、California、美国、95762
- 招聘中
- HiDO Technologies
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接触：
- Charles Gellman
- 电话号码：5138137224
- 邮箱：charles@hidohealth.com
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接触：
- Lisa Marceau
- 电话号码：4014284197
- 邮箱：lmarceau@alphamhealth.com
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首席研究员：
- Charles Gellman
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-
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
- 年长者
接受健康志愿者
不
描述
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.
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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无干预：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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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 to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
大体时间：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
大体时间：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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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。
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5月5日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 5R44AG077737-03 (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)？
是的
IPD 计划说明
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.
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.