Care Coordination System for People With Dementia

NCT04308512 | Completed Results

• 1 other identifier: H-46087
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Dementia Alzheimers

Keywords

Alzheimber; Dementia; care coordination

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months

Secondary Outcomes (3)

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

  3 months

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

  Baseline and 3 months

• Number of Adverse Events Over 3 Month Study

  During the 3 month study

Study Arms (2)

Intervention Group: Care coordination with active Nili System

ACTIVE COMPARATOR

Participants in the intervention group will receive the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.

Behavioral: Active Nili device

Control Group: Receiving passive Nili device

ACTIVE COMPARATOR

Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.

Behavioral: Passive Nili system

Interventions

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.

Intervention Group: Care coordination with active Nili System

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.

Control Group: Receiving passive Nili device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bijan Najafi, PhD: lead
• BioSensics: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Mishra RK, Park C, Momin AS, Rafaei NE, Kunik M, York MK, Najafi B. Care4AD: A Technology-Driven Platform for Care Coordination and Management: Acceptability Study in Dementia. Gerontology. 2023;69(2):227-238. doi: 10.1159/000526219. Epub 2022 Sep 12.

  PMID: 36096091 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Bijan Najafi
• Organization: Baylor College of Medicine

najafi.bijan@gmail.com

(424) 467-7127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 16, 2020
• Study Start: December 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)