Care Coordination System for People With Dementia

October 20, 2025 updated by: Bijan Najafi, PhD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention Group: Care coordination with active Nili System
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
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.
Active Comparator: Control Group: Receiving passive Nili device
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
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.
Baseline and 3 months
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.
During the 3 month study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bijan Najafi, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioSensics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-46087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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