Preventing Medication Mismanagement in People Living With Dementia
18. mai 2026 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Charles Gellman
- Telefonnummer: 510-813-7224
- E-post: charles@hidohealth.com
Studiesteder
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California
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Folsom, California, Forente stater, 95762
- Rekruttering
- HiDO Technologies
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Ta kontakt med:
- Charles Gellman
- Telefonnummer: 5138137224
- E-post: charles@hidohealth.com
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Ta kontakt med:
- Lisa Marceau
- Telefonnummer: 4014284197
- E-post: lmarceau@alphamhealth.com
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Hovedetterforsker:
- Charles Gellman
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. mai 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5R44AG077737-03 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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Charles GellmanFullført