Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

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.

Official Title

Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place

Details

This is a two-arm randomized controlled trial evaluating the HomeCare Pharmacy Distribution System for medication management among adults living with dementia, Alzheimer's disease, or Alzheimer's disease-related dementias.

The study will enroll 120 participants with dementia and their caregivers. Participants will be randomized to either the HomeCare intervention group or a standard-care control group. Participants assigned to the intervention group will use the HomeCare system for medication management. The system is designed to automate medication dispensing, monitor medication adherence, document medication-use patterns, and provide real-time alerts to caregivers. Participants assigned to the control group will continue using traditional medication-management methods, including pill bottles or blister packs.

The primary objective is to evaluate medication adherence over 12 months. Medication adherence will be assessed using the Medication Adherence Rating Scale and Proportion of Days Covered, together with medication-use information collected through the HomeCare system for participants in the intervention group.

Additional outcomes will include hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and behavioral changes related to medication management. Cognitive function will be assessed using the Everyday Cognition assessment at baseline, 6 months, and 12 months. Caregiver burden and quality-of-life measures will also be collected during the study.

Caregivers in both study groups will receive study-related training and will complete surveys and other assessments related to caregiver burden, quality of life, medication-management activities, and their experience supporting the participant.

Participants will be age 65 or older and will have dementia, Alzheimer's disease, or a related dementia. The study will be conducted in collaboration with the University of California, Davis. Participants will be followed for 12 months. Study procedures include regular participant and caregiver follow-up, monitoring for device-related issues and adverse events, and collection of study outcome data.

Safety procedures include participant and caregiver training, regular study-team contact, secure handling of study data, and access to backup medication supplies if technical problems with the HomeCare device occur. Participants may withdraw from the study at any time.

Keywords

Dementia, Alzheimer's Disease and Related Dementias, Medication Adherence, HomeCare, Medication Management, Pharmacy Distribution System, Caregiver Burden, Cognitive Function, Hospitalization, Quality of Life, Video Direct Observed Therapy, Older Adults, Alzheimer Disease

Eligibility

You can join if…

Open to people ages 65 years and up

  • 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.

You CAN'T join if...

  • 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.
  • Residence in a long-term care facility or institutional setting that may limit access to the home-based study intervention.

Location

  • University of California, Davis
    Davis California 95618-6153 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
HiDO Technologies
ID
NCT07872072
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated