Alzheimer Disease, Dementia, Dementia Alzheimers
Conditions
Keywords
Alzheimber, Dementia, care coordination
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.
Interventions
BEHAVIORALActive 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.
BEHAVIORALPassive 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.
Sponsors
BioSensics
Bijan Najafi, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Burden and Stress of Caregivers Over 3 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability, Perception of Benefit, and Ease of Use of Care4AD | 3 months | This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications |
| Change in Baseline Quality of Life at 3 Months: Global PROMIS-10 | 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. |
| Number of Adverse Events Over 3 Month Study | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible dyads will consist of individuals with dementia (IWD) and their caregivers. For this study, outcomes related to caregivers will be presented, as the primary endpoint is the reduction of caregiver burden.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group: Care coordination with active Nili System Dyad participants in the intervention group received the Active Nili system. Essential activities of daily living (ADLs) were preprogrammed by a care coordination expert, and patients and their caregivers could schedule additional tasks through the Nili App. All feedback features were fully activated during the Active Nili Care phase.
The demographics and caregiver outcomes are presented in this report. | 28 |
| Control Group: Care coordination with passive Nili System Dyad 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.
The demographics and caregiver outcomes are presented in this report. | 38 |
| Total | 66 |
Baseline characteristics
| Characteristic | Intervention Group: Care coordination with active Nili System | Control Group: Care coordination with passive Nili System | Total |
|---|---|---|---|
| Age, Continuous Caregivers | 63.4 years STANDARD_DEVIATION 13.5 | 53 years STANDARD_DEVIATION 17.3 | 57.7 years STANDARD_DEVIATION 16.3 |
| Age, Continuous Patients | 70.8 years STANDARD_DEVIATION 13.4 | 70.0 years STANDARD_DEVIATION 11 | 70.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 2 Participants | 15 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 12 Participants | 2 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 9 Participants | 16 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) Caregivers More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers White | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Patients Black or African American | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) Patients More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Patients White | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Caregivers Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Caregivers Male | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Patients Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Patients Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 19 |
| other Total, other adverse events | 0 / 14 | 0 / 19 |
| serious Total, serious adverse events | 0 / 14 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline, 3 months
Population: Change from baseline burden was reported only for caregivers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group: Care coordination with active Nili System | Change in Baseline Burden and Stress of Caregivers Over 3 Months | -52.0 percentage change | Standard Deviation 61.9 |
| Control Group: Receiving passive Nili device | Change in Baseline Burden and Stress of Caregivers Over 3 Months | -31.9 percentage change | Standard Deviation 101.3 |
Secondary
Acceptability, Perception of Benefit, and Ease of Use of Care4AD
This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications
Time frame: 3 months
Secondary
Change in Baseline Quality of Life at 3 Months: Global PROMIS-10
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.
Time frame: Baseline and 3 months
Secondary
Number of Adverse Events Over 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.
Time frame: During the 3 month study
Population: Adverse events were reported for patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group: Care coordination with active Nili System | Number of Adverse Events Over 3 Month Study | 0 Participants |
| Control Group: Receiving passive Nili device | Number of Adverse Events Over 3 Month Study | 0 Participants |