Trial Outcomes & Findings for Care Coordination System for People With Dementia (NCT NCT04308512)

Last Updated: 2025-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2025-11-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Intervention Group: Care coordination with active Nili System Participants in the intervention group received 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.	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.
Overall Study STARTED	28	38
Overall Study Number of caregivers	14	19
Overall Study Number of patients	14	19
Overall Study COMPLETED	22	32
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Change from baseline burden was reported only for caregivers.

Outcome measures

Outcome measures
Measure	Control Group: Receiving passive Nili device n=16 Participants 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.	Intervention Group: Care coordination with active Nili System n=11 Participants Participants in the intervention group received 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.
Change in Baseline Burden and Stress of Caregivers Over 3 Months	-31.9 percentage change Standard Deviation 101.3	-52.0 percentage change Standard Deviation 61.9

SECONDARY outcome

Timeframe: 3 months

This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 3 month study

Population: Adverse events were reported for patients.

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.

Outcome measures

Outcome measures
Measure	Control Group: Receiving passive Nili device n=19 Participants 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.	Intervention Group: Care coordination with active Nili System n=14 Participants Participants in the intervention group received 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.
Number of Adverse Events Over 3 Month Study	0 Participants	0 Participants

Adverse Events

Intervention Group: Care coordination with active Nili System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group: Receiving passive Nili device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bijan Najafi

Baylor College of Medicine

Phone: (424) 467-7127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Intervention Group: Care coordination with active Nili System n=28 Participants 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.	Control Group: Care coordination with passive Nili System n=38 Participants 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.	Total n=66 Participants Total of all reporting groups
Sex: Female, Male Patients · Female	9 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	18 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Sex: Female, Male Patients · Male	5 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	10 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	15 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Caregivers · Hispanic or Latino	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Caregivers · Not Hispanic or Latino	2 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	15 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	17 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Caregivers · Unknown or Not Reported	12 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	14 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Patients · Hispanic or Latino	3 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	5 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · Black or African American	9 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	18 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · White	3 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	6 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · American Indian or Alaska Native	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · Asian	1 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	1 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · Unknown or Not Reported	2 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	4 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Age, Continuous Caregivers	63.4 years STANDARD_DEVIATION 13.5 • n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	53 years STANDARD_DEVIATION 17.3 • n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	57.7 years STANDARD_DEVIATION 16.3 • n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Age, Continuous Patients	70.8 years STANDARD_DEVIATION 13.4 • n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	70.0 years STANDARD_DEVIATION 11.0 • n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	70.3 years STANDARD_DEVIATION 11.9 • n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Sex: Female, Male Caregivers · Female	10 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	14 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	24 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Sex: Female, Male Caregivers · Male	4 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	5 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Patients · Not Hispanic or Latino	9 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	16 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	25 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Ethnicity (NIH/OMB) Patients · Unknown or Not Reported	2 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	1 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	3 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · American Indian or Alaska Native	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · Asian	1 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	1 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	0 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · More than one race	1 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	1 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Caregivers · Unknown or Not Reported	0 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · Black or African American	7 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	16 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · White	3 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	6 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	9 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group
Race (NIH/OMB) Patients · More than one race	1 Participants n=14 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	1 Participants n=19 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group	2 Participants n=33 Participants • A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group