NCT04308512

Care Coordination System for People With Dementia

A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Bijan Najafi, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectiveness of a home-based care coordination and management device, called Care4AD (Nili device) to help caregivers effectively coordinate, manage, and improve dementia care.

Detailed description

In this study, the investigator will evaluate the effectiveness of a supportive care coordination device, Care4AD/Nili, in reducing caregiver burden and stress, improving adherence to scheduled tasks, and increasing engagement among individuals with dementia (IWD). A 3-month randomized controlled trial (RCT) will be conducted with an anticipated 100 caregiver-patient dyads, consisting of 50 individuals with dementia or cognitive impairment and their 50 primary caregivers. Dyads will be randomized in a 1:1 ratio to receive either (1) a Passive Nili device (preprogrammed care coordination with limited daily programmability) for three months, or (2) an Active Nili device for three months. The Active Nili device offers interactive, personalized programming with real-time notifications, task logging, and enhanced social and cognitive engagement features, including photo sharing, phone calls, music, and audiobooks. The primary outcome is change in caregiver burden. Secondary outcomes include usability metrics such as perceived ease of use, perceived benefit, technology-related anxiety, and overall attitudes toward adoption.

Conditions

• Alzheimer Disease
• Dementia
• Dementia Alzheimers

Interventions

Type	Name	Description
BEHAVIORAL	Active Nili device	Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.
BEHAVIORAL	Passive Nili system	Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2020-03-16
• Last updated: 2025-11-05
• Results posted: 2025-11-05

Locations

1 site across 1 country: United States