Trial Outcomes & Findings for Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE) (NCT NCT03119259)
NCT ID: NCT03119259
Last Updated: 2024-09-19
Results Overview
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
15 month accrual period
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Usual Care
Dyads of informal caregivers plus patients randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health.
The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary.
|
Brain CareNotes (BCN) Software
Dyads of informal caregivers plus patients randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Usual Care
Dyads of informal caregivers plus patients randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health.
The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary.
|
Brain CareNotes (BCN) Software
Dyads of informal caregivers plus patients randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Overall Study
Withdrawn as no longer eligible
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Age unknown for 4 participants
Baseline characteristics by cohort
| Measure |
Usual Care (Caregiver Characteristics)
n=27 Participants
Dyads of informal caregivers plus patients randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health.
The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary.
|
Brain CareNotes (BCN) Software (Caregiver Characteristics)
n=26 Participants
Dyads of informal caregivers plus patients randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
Usual Care (Patient Characteristics)
n=27 Participants
Dyads of informal caregivers plus patients randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health.
The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary.
|
Brain CareNotes (BCN) Software (Patient Characteristics)
n=26 Participants
Dyads of informal caregivers plus patients randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 13.0 • n=27 Participants • Age unknown for 4 participants
|
62.5 years
STANDARD_DEVIATION 13.7 • n=26 Participants • Age unknown for 4 participants
|
77.2 years
STANDARD_DEVIATION 9.9 • n=25 Participants • Age unknown for 4 participants
|
76.0 years
STANDARD_DEVIATION 10.6 • n=24 Participants • Age unknown for 4 participants
|
62.9 years
STANDARD_DEVIATION 13.2 • n=102 Participants • Age unknown for 4 participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=27 Participants • Sex unknown for 2 participants
|
19 Participants
n=26 Participants • Sex unknown for 2 participants
|
18 Participants
n=25 Participants • Sex unknown for 2 participants
|
15 Participants
n=26 Participants • Sex unknown for 2 participants
|
74 Participants
n=104 Participants • Sex unknown for 2 participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=27 Participants • Sex unknown for 2 participants
|
7 Participants
n=26 Participants • Sex unknown for 2 participants
|
7 Participants
n=25 Participants • Sex unknown for 2 participants
|
11 Participants
n=26 Participants • Sex unknown for 2 participants
|
30 Participants
n=104 Participants • Sex unknown for 2 participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
25 Participants
n=27 Participants
|
25 Participants
n=26 Participants
|
101 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=106 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=27 Participants
|
12 Participants
n=26 Participants
|
10 Participants
n=27 Participants
|
12 Participants
n=26 Participants
|
46 Participants
n=106 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=27 Participants
|
14 Participants
n=26 Participants
|
16 Participants
n=27 Participants
|
13 Participants
n=26 Participants
|
57 Participants
n=106 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Marital status
Married
|
22 Participants
n=27 Participants
|
16 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
38 Participants
n=106 Participants
|
|
Marital status
Living with partner
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=106 Participants
|
|
Marital status
Divorced
|
2 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=106 Participants
|
|
Marital status
Separated
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=106 Participants
|
|
Marital status
Never married
|
3 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
9 Participants
n=106 Participants
|
|
Marital status
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Caregiver living situation
Lives with spouse
|
19 Participants
n=27 Participants
|
14 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
33 Participants
n=106 Participants
|
|
Caregiver living situation
Lives with children's family
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Caregiver living situation
Lives with spouse and children's family
|
3 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Caregiver living situation
Lives alone
|
1 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=106 Participants
|
|
Caregiver living situation
Other
|
3 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Caregiver living situation
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Insurance
Medicare
|
2 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Insurance
Medicaid
|
3 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=106 Participants
|
|
Insurance
Medicare + Medicaid
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Insurance
Private/commercial
|
7 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
14 Participants
n=106 Participants
|
|
Insurance
Medicare + Private
|
12 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
22 Participants
n=106 Participants
|
|
Insurance
Self Pay/None
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Insurance
Private + Self Pay
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Insurance
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Employment
Employed full time (40 hours or more)
|
9 Participants
n=27 Participants
|
8 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
17 Participants
n=106 Participants
|
|
Employment
Employed part time (less than 40 hours)
|
0 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Employment
Unemployed
|
0 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=106 Participants
|
|
Employment
Retired
|
13 Participants
n=27 Participants
|
12 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
25 Participants
n=106 Participants
|
|
Employment
Homemaker
|
3 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Employment
On social security or disability
|
2 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Employment
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Income
$10,000 or less
|
0 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=106 Participants
|
|
Income
$10,001 to $30,000
|
8 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
15 Participants
n=106 Participants
|
|
Income
$30,001 to $50,000
|
6 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
13 Participants
n=106 Participants
|
|
Income
$50,001 to $75,000
|
4 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=106 Participants
|
|
Income
$75,001 to $100,000
|
4 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Income
$100,001 or above
|
4 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Income
Unknown
|
1 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=106 Participants
|
|
Income
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Education
Grade School or Middle School
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Education
Some High School
|
3 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=106 Participants
|
|
Education
High School Graduate or GED
|
6 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
10 Participants
n=106 Participants
|
|
Education
Some College
|
4 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
10 Participants
n=106 Participants
|
|
Education
College Degree
|
6 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
12 Participants
n=106 Participants
|
|
Education
Masters or other advanced degree
|
8 Participants
n=27 Participants
|
8 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
16 Participants
n=106 Participants
|
|
Education
Unknown
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Education
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Years caring for person with ADRD
1 year or less
|
4 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=106 Participants
|
|
Years caring for person with ADRD
2 years
|
3 Participants
n=27 Participants
|
5 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=106 Participants
|
|
Years caring for person with ADRD
3 years
|
7 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
11 Participants
n=106 Participants
|
|
Years caring for person with ADRD
4 years
|
3 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
7 Participants
n=106 Participants
|
|
Years caring for person with ADRD
5 years
|
4 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Years caring for person with ADRD
6 years or more
|
6 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
13 Participants
n=106 Participants
|
|
Years caring for person with ADRD
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Hours per day spent caregiving
0-1 hours
|
1 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=106 Participants
|
|
Hours per day spent caregiving
2-5 hours
|
3 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
9 Participants
n=106 Participants
|
|
Hours per day spent caregiving
6-9 hours
|
8 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=106 Participants
|
|
Hours per day spent caregiving
10-13 hours
|
5 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=106 Participants
|
|
Hours per day spent caregiving
14-17 hours
|
3 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=106 Participants
|
|
Hours per day spent caregiving
18+ hours
|
7 Participants
n=27 Participants
|
11 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
18 Participants
n=106 Participants
|
|
Hours per day spent caregiving
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Never
|
19 Participants
n=27 Participants
|
16 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
35 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Rarely
|
7 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
13 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Sometimes
|
1 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Often
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Always
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=106 Participants
|
|
Single Item Literacy Screener
Not measured
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
53 Participants
n=106 Participants
|
|
Study site
Eskenazi Health
|
17 Participants
n=27 Participants
|
16 Participants
n=26 Participants
|
17 Participants
n=27 Participants
|
16 Participants
n=26 Participants
|
66 Participants
n=106 Participants
|
|
Study site
IU Health
|
10 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
10 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
40 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: 15 month accrual periodPopulation: Caregivers recruited to the study
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Outcome measures
| Measure |
All Participants
n=61 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: Recruitment Rate
|
4.1 participants recruited per month
Standard Deviation 4.1
|
—
|
PRIMARY outcome
Timeframe: 6 months after enrollment and randomizationData completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: Data Completeness
3 months
|
19 Participants
|
21 Participants
|
|
Feasibility: Data Completeness
6 months
|
22 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 3 monthsBCN usability at 3 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 (worst outcome) to 100 (best outcome).
Outcome measures
| Measure |
All Participants
n=20 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: BCN Usability (3 Months)
|
76.3 score on a scale
Interval 66.3 to 83.8
|
—
|
PRIMARY outcome
Timeframe: 6 monthsBCN usability at 6 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 to 100. Higher scores indicate higher usability.
Outcome measures
| Measure |
All Participants
n=21 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: BCN Usability (6 Months)
|
72.5 score on a scale
Interval 70.0 to 90.0
|
—
|
PRIMARY outcome
Timeframe: 3 monthsAcceptance at 3 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal). Higher scores indicate higher acceptance.
Outcome measures
| Measure |
All Participants
n=17 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: BCN Acceptance (3 Months)
|
2 score on a scale
Interval 1.5 to 4.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsAcceptance at 6 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal).
Outcome measures
| Measure |
All Participants
n=21 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Feasibility: BCN Acceptance (6 Months)
|
2.0 score on a scale
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: baselineInformal caregiver burden at baseline, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Caregiver Burden (Baseline)
|
9.8 score on a scale
Standard Deviation 7.4
|
8.5 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 3 monthsInformal caregiver burden at 3 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Caregiver Burden (3 Months)
|
10.9 score on a scale
Standard Deviation 8.2
|
7.5 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 6 monthsInformal caregiver burden at 6 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Caregiver Burden (6 Months)
|
8.8 score on a scale
Standard Deviation 7.0
|
7.8 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: baselineSeverity of patient behavioral and psychological symptoms of dementia (BPSD) at baseline, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
BPSD Severity (Baseline)
|
17.2 score on a scale
Standard Deviation 15.5
|
16.4 score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 3 monthsSeverity of patient behavioral and psychological symptoms of dementia (BPSD) at 3 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
BPSD Severity (3 Months)
|
18.3 score on a scale
Standard Deviation 15.1
|
12.4 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 6 monthsSeverity of patient behavioral and psychological symptoms of dementia (BPSD) at 6 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
Outcome measures
| Measure |
All Participants
n=27 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=26 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
BPSD Severity (6 Months)
|
18.5 score on a scale
Standard Deviation 16.0
|
15.9 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 3 monthsNumber of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention).
Outcome measures
| Measure |
All Participants
n=19 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=21 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Acute Care Utilization (3 Months)
Patients
|
7 Participants
|
13 Participants
|
|
Acute Care Utilization (3 Months)
Caregivers
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of all-cause hospital and emergency room admissions among patients and caregivers in the last 3 months (at 6 months post-intervention).
Outcome measures
| Measure |
All Participants
n=22 Participants
All participants, prior to assignment to condition
|
Brain CareNotes (BCN) Software
n=23 Participants
Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software.
BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders.
BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support:
1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.
|
|---|---|---|
|
Acute Care Utilization (6 Months)
Patients
|
3 Participants
|
13 Participants
|
|
Acute Care Utilization (6 Months)
Caregivers
|
5 Participants
|
3 Participants
|
Adverse Events
Usual Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brain CareNotes (BCN) Software - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Brain CareNotes (BCN) Software - Patients
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place