Clinical trial NCT06691256: Preventing Medication Mismanagement in People Living with Dementia Through Automated Medication Dispensing with Facial Recognition and Video Observation
Official title: Preventing Medication Mismanagement in People Living with Dementia Through Automated Medication Dispensing with Facial Recognition and Video Observation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: HiDO Technologies
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
First posted: 2024-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Medication adherence: Percentage of Doses Taken as Prescribed Over 12 Months
timeFrame: Measurements are collected daily and weekly over 12 months.
measure: Change in Health Biomarker: Change in Glucose Levels (mg/dL) Over 12 Months
timeFrame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
measure: Change in Health Biomarker: Change in HbA1c Levels (%) Over 12 Months
timeFrame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
measure: Change in Health Biomarker: Change in Creatinine Levels (mg/dL) Over 12 Months
timeFrame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
measure: Change in Health Biomarker: Change in Glomerular Filtration Rate (GFR) (mL/min/1.73 m²) Over 12 Months
timeFrame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
Secondary outcomes:
measure: Monthly Weight Tracking
timeFrame: Measurements are taken monthly over the 12-month study duration.
measure: Blood Pressure Monitoring (mmHg)
timeFrame: Measurements are taken monthly over the 12-month study duration.
measure: Monthly Heart Rate Tracking (beats per minute)
timeFrame: Measurements are taken monthly over the 12-month study duration.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: