Preventing Medication Mismanagement in People Living With Dementia

Официальное название

Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство HiDO HomeCareSystem
  Participants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.

Первичные конечные точки

• Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score [Срок оценки: baseline and 12-months]
• Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score [Срок оценки: Baesline, 4, 8, and 12 month timepoints]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• HiDO Technologies — Folsom

Идентификаторы

NCT: NCT07600684 · 5R44AG077737-03 · 5R44AG077737-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗