HomeCare Medication Management for People With Dementia

ConditionsDementia Alzheimer's Disease and Related Dementias

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorHiDO Technologies

About this trial

This study will evaluate whether the HomeCare medication management system can improve medication adherence and related outcomes for adults age 65 and older living with dementia, Alzheimer's disease, or related dementias.

HomeCare is an internet-connected medication management device that can automate medication dispensing, monitor medication use, and provide alerts to caregivers. The system is integrated with a Pharmacy Distribution System designed to track medications from pharmacy delivery through use in the home.

A total of 120 participants with dementia will be randomly assigned to one of two groups. One group will use the HomeCare system, while the other group will continue using standard medication management methods, such as pill bottles or blister packs. Participants will be followed for 12 months. The main outcome is medication adherence. The study will also examine hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and changes in medication-management behavior. Caregivers will also participate in surveys and study assessments. The study is intended to determine whether HomeCare can improve medication management and support both people living with dementia and their caregivers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 65 years or older.

Living with dementia, Alzheimer's Disease, or Alzheimer's Disease Related Dementias (AD/ADRD) according to standardized diagnostic criteria.

Capable of providing informed consent or have a legally authorized representative available to consent on their behalf.

Access to a smartphone, tablet, or computer with internet connectivity. Able to communicate in either English or Spanish.

Disqualifiers

Significant comorbidities or medical conditions that could interfere with participation or severe cognitive function.

History of severe psychiatric illness or substance abuse disorder.

Recent participation in other clinical trials targeting cognition or dementia.

Unwillingness or inability to comply with study procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

HomeCare
Device
An automated, secure, AI driven medication delivery and observation platform to maximize therapy compliance, provide continuous medication monitoring and outcomes for individuals impacted by AD/ADRD.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: HomeCare System (Intervention Group)Experimental treatment 1 intervention

Group B: Standard of Care (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

Medication Adherence

Medication adherence will be assessed using the Medication Adherence Rating Scale (MARS) and Proportion of Days Covered (PDC). The HomeCare system will track adherence through its automated logging of medication usage and AI-powered monitoring algorithms.

Time frame

12 months

Secondary outcomes

Incidence of Hospitalizations

The frequency of hospitalizations and emergency room visits will be recorded and compared between the intervention and control groups.

Time frame

12 months

ECOG Cognitive Assessment

The ECOG assessment will measure changes in cognitive function over the study period.

Time frame

Baseline, 6 months, 12 months

Zarit Burden Interview (ZBI) Score

Caregiver burden will be evaluated using the Zarit Burden Interview, a validated tool for assessing the psychological impact on caregivers.

Time frame

Baseline, 6 months, 12 months

Other outcomes

Behavioral Changes in Medication Management

Assess the effectiveness of HomeCare's interventions (e.g., SMS notifications, video messages) on altering patient behavior regarding medication adherence.

Time frame

12 months

EQ-5D-5L Health Questionnaire

The EQ-5D-5L will assess health-related quality of life for patients and caregivers.

Time frame

Baseline, 6 months, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HiDO Technologies

Lead sponsor

National Institute on Aging (NIA)

Collaborator

University of California, Davis

Collaborator

Source ClinicalTrials.gov

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