A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Bijan Najafi, PhD
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in Baseline Burden and Stress of Caregivers Over 3 Months
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
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.
Investigators
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
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
- 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)