Trial results for a care coordination system for people with Alzheimer's Disease were posted on ClinicalTrials.gov on 2025-11-05, showing a mean reduction of 52.0% in caregiver burden for the intervention group.
Background
Dementia, including Alzheimer's Disease, is a chronic condition characterized by progressive cognitive decline that impacts independent functioning. This creates significant stress for patients, their caregivers, and families due to the medical, psychological, social, and functional challenges involved. Effective tools and systems are crucial to help caregivers manage and improve dementia care, addressing the multifaceted needs of this population.
Trial design
This completed study, designated as Phase NA, enrolled 33 participants diagnosed with conditions including Alzheimer Disease, Dementia, and Dementia Alzheimers. The trial investigated the effectiveness of a home-based care coordination and management device, referred to as the Care4AD (Nili device). Participants were assigned to either an intervention group receiving active care coordination with the Nili System or a control group receiving a passive Nili device.
Key results
The trial reported key measurements related to caregiver burden and adverse events over a three-month study period:
- Change in Baseline Burden and Stress of Caregivers Over 3 Months:
- In the Intervention Group (active Nili System), the mean change was -52.0 percentage change (Standard Deviation 61.9).
- In the Control Group (passive Nili device), the mean change was -31.9 percentage change (Standard Deviation 101.3).
- Number of Adverse Events Over 3 Month Study:
- In the Intervention Group (active Nili System), 0 Participants experienced adverse events.
- In the Control Group (passive Nili device), 0 Participants experienced adverse events.
What this means
The results indicate that the active care coordination system (Nili System) led to a greater mean reduction in caregiver burden and stress over three months compared to the passive device. Specifically, the intervention group experienced a 52.0% mean reduction, while the control group saw a 31.9% mean reduction. Additionally, the study reported no adverse events in either the active intervention or control groups, suggesting a favorable safety profile for the device during the study period. These findings suggest potential benefits of active care coordination systems in supporting caregivers of individuals with Alzheimer's Disease.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04308512, titled "Care Coordination System for People With Dementia", were posted on 2025-11-05 on clinicaltrials.gov.