Automated Medication Dispensing for Dementia

Recruiting in Palo Alto (17 mi)

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: HiDO Technologies

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Globally, \>47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs \>$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& 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, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.

Eligibility Criteria

This trial is for individuals with dementia, such as Alzheimer's Disease, who also may have type 2 diabetes. Participants should struggle with medication management and adherence. They must be able to use the HiDO-ALZ device which dispenses medications automatically using facial recognition and video monitoring.

Inclusion Criteria

Mild cognitive impairment or early-stage dementia, as verified by a Montreal Cognitive Assessment (MoCA) score between 18 and 24

I am 65 years old or older.

I have dementia and diabetes and struggle to keep my health markers like glucose or blood pressure in target ranges.

Exclusion Criteria

Cognitive deficits or serious mental health or medical conditions that would compromise safety or the reliability of feedback

I cannot take low-dose Vitamin C due to health reasons.

Participant Groups

The HiDO-ALZ platform is being tested to see if it can help people with dementia manage their medications better by automating dispensing and providing caregivers access to adherence data through a cloud-connected dashboard.

2Treatment groups

Experimental Treatment

Active Control

Group I: Field Efficacy Study - Experimental GroupExperimental Treatment1 Intervention

Participants in the experimental group will receive the HiDO-ALZ platform for 12 months, which provides automated medication dispensing, real-time facial recognition to ensure correct medication delivery, and biometric monitoring for blood pressure and weight. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the usability and human factors of the HiDO-ALZ platform.

Group II: Field Efficacy Study - Control GroupActive Control1 Intervention

Participants in the control group will receive standard care without the HiDO-ALZ device. They will continue with their usual medication routines and any standard biometric monitoring methods as directed by their healthcare providers. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the standard of care and not using the HiDO-ALZ device.