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

NCT06691256 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: R44AG077737
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia; Medication Adherence; Type 2 Diabetes Mellitus (T2DM)

Keywords

people with dementia (PwD); Dementia; Alzheimer Disease; Medication Management; Medication Adherence; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (5)

• Medication adherence: Percentage of Doses Taken as Prescribed Over 12 Months

  The primary outcome focuses on improving medication adherence among participants using the HiDO-ALZ system, as compared to standard care. Medication adherence is measured through the system's automated monitoring, which utilizes facial recognition to verify identity and track each dose administered. The HiDO-ALZ platform records the timing and accuracy of each dose taken, providing a comprehensive adherence rate over the study period. This adherence data will be evaluated against adherence rates in the standard care group, aiming to demonstrate the system's effectiveness in reducing missed doses and optimizing medication management for individuals with dementia.

  Measurements are collected daily and weekly over 12 months.

• Change in Health Biomarker: Change in Glucose Levels (mg/dL) Over 12 Months

  This outcome measures the average change in blood glucose levels for participants in the experimental group using the HiDO-ALZ system compared to the control group receiving standard care. Blood glucose levels will be measured at baseline, 6 months, and 12 months, with the change calculated as the difference from baseline to each subsequent time point. Unit of Measure: Milligrams per Deciliter (mg/dL)

  Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.

• Change in Health Biomarker: Change in HbA1c Levels (%) Over 12 Months

  This outcome measures the average change in HbA1c levels for participants in the experimental group compared to the control group. HbA1c levels will be monitored at baseline, 6 months, and 12 months, with changes calculated as the difference from baseline. Unit of Measure: Percentage (%)

  Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.

• Change in Health Biomarker: Change in Creatinine Levels (mg/dL) Over 12 Months

  This outcome measures the average change in serum creatinine levels for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values. Unit of Measure: Milligrams per Deciliter (mg/dL)

  Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.

• Change in Health Biomarker: Change in Glomerular Filtration Rate (GFR) (mL/min/1.73 m²) Over 12 Months

  This outcome measures the average change in GFR, an indicator of kidney function, for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values. Unit of Measure: Milliliters per Minute per 1.73 m² (mL/min/1.73 m²)

  Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.

Secondary Outcomes (3)

• Monthly Weight Tracking

  Measurements are taken monthly over the 12-month study duration.

• Blood Pressure Monitoring (mmHg)

  Measurements are taken monthly over the 12-month study duration.

• Monthly Heart Rate Tracking (beats per minute)

  Measurements are taken monthly over the 12-month study duration.

Study Arms (2)

Field Efficacy Study - Experimental Group

EXPERIMENTAL

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.

Device: HiDO-ALZ

Field Efficacy Study - Control Group

NO 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.

Interventions

HiDO-ALZ DEVICE

HiDO-ALZ platform, an AI-driven medication dispensing and observation system designed to improve adherence in individuals with dementia and diabetes.

Field Efficacy Study - Experimental Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants aged 65 or older.
• Diagnosed with both dementia and diabetes, with documented difficulty in maintaining at least one health marker (such as glucose, HbA1c, cholesterol, blood pressure, or weight) within target levels over the past 18-24 months.
• Mild cognitive impairment or early-stage dementia, as verified by a Montreal Cognitive Assessment (MoCA) score between 18 and 24.

You may not qualify if:

• Cognitive deficits or serious mental health or medical conditions that would compromise safety or the reliability of feedback.
• Contraindications to taking low-dose Vitamin C (100 mg).

Sponsors & Collaborators

• HiDO Technologies: lead
• Rush University Medical Center: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Medication Adherence; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Phase 2 study model for HiDO-ALZ uses a dual-study approach to refine and validate the platform: Field Efficacy Study: Building on in-clinic findings, this home-based trial enrolls participants in a 12-month randomized controlled study to assess the HiDO-ALZ's impact on medication adherence and health outcomes, such as adherence rates and biometric trends.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 15, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (1)