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Completed

NCT Number: NCT04308512

Care Coordination System for People With Dementia

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Dementia Alzheimers Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Nili device

Behavioral

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 system

Behavioral

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.

Primary outcomes

  1. Change in Baseline Burden and Stress of Caregivers Over 3 Months

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: 3 months

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

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

    Time frame: Baseline and 3 months

    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.

  3. Number of Adverse Events Over 3 Month Study

    Time frame: During the 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.

Sponsors and collaborators

Lead sponsor

Bijan Najafi, PhD

Other

Collaborators

  • BioSensics

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2020
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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