N/A
N=66
Care Coordination System for People With Dementia
Alzheimer Disease · Dementia · Dementia Alzheimers
Bottom Line
View on ClinicalTrials.gov: NCT04308512 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Baseline Burden and Stress of Caregivers Over 3 Months — -52.0; -31.9 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Nili device (Behavioral); Passive Nili system (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bijan Najafi, PhD
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Burden and Stress of Caregivers Over 3 Months |
-52.0; -31.9 | — |
| SECONDARY Acceptability, Perception of Benefit, and Ease of Use of Care4AD |
— | — |
| SECONDARY Change in Baseline Quality of Life at 3 Months: Global PROMIS-10 |
— | — |
| SECONDARY Number of Adverse Events Over 3 Month Study |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04308512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.