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Preventing Medication Mismanagement in People Living With Dementia

18 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhet: 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.
Inget ingripande: Standard Medication Management
Participants randomized to Standard Medication Management will continue taking medication as usual, without the assitance of the HiDO HCS.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
Tidsram: baseline and 12-months
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.
baseline and 12-months
Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score
Tidsram: Baesline, 4, 8, and 12 month timepoints
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.
Baesline, 4, 8, and 12 month timepoints

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

HiDO Technologies

Samarbetspartners

National Institute on Aging (NIA)
University of California, Davis

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 maj 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 5R44AG077737-03 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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