NCT04308512 - Care Coordination System for People With Dementia | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

33

Conditions

Alzheimer Disease Dementia Dementia Alzheimers

Interventions

Active Nili deviceBEHAVIORAL

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.

Passive Nili systemBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria include: * Caregivers (\>18 years old) taking care of older patients (\> 55 years old) with mild or moderate Alzheimer's Disease or self-reported memory problems and MOCA score of 26 or lower. * Must be ambulatory * Must be in a residential home with a caregiver/informant. Exclusion Criteria: * Immobility or inability to engage in activities that are essential for independent living (e.g., patients with severe dementia); * Any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study * Major hearing/visual impairment; * Residing in a nursing home or are receiving hospice care; * Inability to communicate in English or Spanish; * Unavailability or unwillingness of the caregiver of the patient to attend the interview.

Locations (1)

Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Baseline Burden and Stress of Caregivers Over 3 Months

Caregiver burden and stress will be assessed using the 12-item short version of the Zarit Burden Interview (ZBI), a validated survey for dementia caregivers. The ZBI evaluates caregivers' experiences across emotional, physical, and social domains, capturing the strains and difficulties associated with their role. Items address issues such as perceived decline in personal health, the impact of caregiving on relationships with family and friends, and overall feelings of burden. Percentage change from baseline to 3 months will be calculated. Change from baseline burden was reported only for caregivers. Percentage change on the ZBI-12 can range from -100% (complete resolution of burden) to a large positive increase, with negative values indicating improvement and positive values indicating worsening; reductions of 20% or more are generally considered clinically meaningful improvements.

Time frame: Baseline, 3 months

Secondary Outcomes

Acceptability, Perception of Benefit, and Ease of Use of Care4AD

This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications

Time frame: 3 months

Change in Baseline Quality of Life at 3 Months: Global PROMIS-10

Quality of life will be assessed using a validated questionnaire, called Global PROMIS-10. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The "7+2" scales include the same global health score plus one fatigue and one pain interference item which are scored independently.

Time frame: Baseline and 3 months

Number of Adverse Events Over 3 Month Study

Adverse events, including falls, dehydration, urinary tract infections, and emergency department visits, were systematically monitored over a 3-month period. These events were reported exclusively for patients.

Time frame: During the 3 month study