Dementia, Alzheimer Type
Conditions
Brief summary
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia (BPSD) at 6 months. Subjects will be recruited from the Aging Brain Care (ABC) program of Eskenazi Health and Indiana University Health located in central Indiana.
Detailed description
Informal caregivers of patients with Alzheimer's disease and related dementia (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). BPSD are major contributing factors to caregivers' burden and adverse health outcomes, leading to an increase of unplanned hospitalizations and a decrease in quality of life. The National Alzheimer's Project Act recognizes the need for interventions that enable family caregivers to continue to provide care while maintaining their own health and well-being. Furthermore, recommendations from 2015 and 2018 Alzheimer's Disease Research Summits include the application of technology to improve caregiving research and ADRD care This pilot randomized controlled trial, will test the feasibility and estimate the effect size of integrating mobile health technology BrainCare Notes (BCN) into an existing, fully operational, and self-sustaining clinical program (Aging Brain Care; ABC) and IU Health primary care physician clinics (IUHP). BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementia (ADRD). The BCN app delivers 24/7 psychoeducation and caregiver support, assessment of informal caregiver status and patients' behavioral and psychological symptoms of dementia (BPSD), and engagement tools for self-management and communication. Over a 15 month accrual period, we propose to enroll from the ABC clinical program and IUHP 60 dyads consisting of an adult patient with ADRD and one (primary) informal caregiver. The intervention will continue for 6 months and final assessments will be completed at 6 months. Feasibility data will be collected throughout the study and assessed at the end of the study by computing: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use. Caregiver burden and patient BPSD will be collected at baseline, 3, and 6 months and evaluated for changes from baseline to 6 months in each group. Means, standard deviations, and confidence intervals will be computed to test feasibility hypotheses. Mixed linear models will be used to test hypotheses comparing the two conditions at 6 months.
Interventions
BEHAVIORALABC 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. The ABC Clinical Program is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver 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 goal of IUHP Usual Care is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and refered to brain care specialty as necessary.
BEHAVIORALBCN
BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementias (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.
Sponsors
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has received a diagnosis of possible or probable Alzheimer's disease and Related Dementia from a physician in the ABC Clinical Program; * Caregiver is at least 18 years of age and does not have a visual impairment significant enough to interfere with his/her ability to use BCN; * Both patient and caregiver are community-dwelling in central Indiana; and * Both patient and caregiver are willing to participate in the ABC Clinical Program (including receiving home visits).
Exclusion criteria
* Either the patient or his/her informal caregiver does not have the ability to communicate in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Recruitment Rate | 15 month accrual period | Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period. |
| Feasibility: Data Completeness | 6 months after enrollment and randomization | Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months. |
| Feasibility: BCN Usability (3 Months) | 3 months | BCN 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). |
| Feasibility: BCN Usability (6 Months) | 6 months | BCN 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. |
| Feasibility: BCN Acceptance (3 Months) | 3 months | Acceptance 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. |
| Feasibility: BCN Acceptance (6 Months) | 6 months | Acceptance 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Care Utilization (3 Months) | 3 months | Number of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention). |
| Caregiver Burden (Baseline) | baseline | Informal 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) |
| Acute Care Utilization (6 Months) | 6 months | Number of all-cause hospital and emergency room admissions among patients and caregivers in the last 3 months (at 6 months post-intervention). |
| Caregiver Burden (3 Months) | 3 months | Informal 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) |
| Caregiver Burden (6 Months) | 6 months | Informal 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) |
| BPSD Severity (Baseline) | baseline | Severity 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). |
| BPSD Severity (3 Months) | 3 months | Severity 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). |
| BPSD Severity (6 Months) | 6 months | Severity 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (Caregiver Characteristics) 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. | 27 |
| Brain CareNotes (BCN) Software (Caregiver Characteristics) 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. | 26 |
| Usual Care (Patient Characteristics) 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. | 27 |
| Brain CareNotes (BCN) Software (Patient Characteristics) 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. | 26 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
| Overall Study | Withdrawn as no longer eligible | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Brain CareNotes (BCN) Software (Patient Characteristics) | Usual Care (Patient Characteristics) | Brain CareNotes (BCN) Software (Caregiver Characteristics) | Usual Care (Caregiver Characteristics) |
|---|---|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 13.2 | 76.0 years STANDARD_DEVIATION 10.6 | 77.2 years STANDARD_DEVIATION 9.9 | 62.5 years STANDARD_DEVIATION 13.7 | 63.3 years STANDARD_DEVIATION 13 |
| Caregiver living situation Lives alone | 5 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants |
| Caregiver living situation Lives with children's family | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Caregiver living situation Lives with spouse | 33 Participants | 0 Participants | 0 Participants | 14 Participants | 19 Participants |
| Caregiver living situation Lives with spouse and children's family | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Caregiver living situation Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Caregiver living situation Other | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Education College Degree | 12 Participants | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Education Grade School or Middle School | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education High School Graduate or GED | 10 Participants | 0 Participants | 0 Participants | 4 Participants | 6 Participants |
| Education Masters or other advanced degree | 16 Participants | 0 Participants | 0 Participants | 8 Participants | 8 Participants |
| Education Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Education Some College | 10 Participants | 0 Participants | 0 Participants | 6 Participants | 4 Participants |
| Education Some High School | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Education Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Employment Employed full time (40 hours or more) | 17 Participants | 0 Participants | 0 Participants | 8 Participants | 9 Participants |
| Employment Employed part time (less than 40 hours) | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Employment Homemaker | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Employment Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Employment On social security or disability | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Employment Retired | 25 Participants | 0 Participants | 0 Participants | 12 Participants | 13 Participants |
| Employment Unemployed | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 25 Participants | 25 Participants | 26 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Hours per day spent caregiving 0-1 hours | 4 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Hours per day spent caregiving 10-13 hours | 8 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Hours per day spent caregiving 14-17 hours | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Hours per day spent caregiving 18+ hours | 18 Participants | 0 Participants | 0 Participants | 11 Participants | 7 Participants |
| Hours per day spent caregiving 2-5 hours | 9 Participants | 0 Participants | 0 Participants | 6 Participants | 3 Participants |
| Hours per day spent caregiving 6-9 hours | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Hours per day spent caregiving Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Income $100,001 or above | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Income $10,000 or less | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Income $10,001 to $30,000 | 15 Participants | 0 Participants | 0 Participants | 7 Participants | 8 Participants |
| Income $30,001 to $50,000 | 13 Participants | 0 Participants | 0 Participants | 7 Participants | 6 Participants |
| Income $50,001 to $75,000 | 8 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Income $75,001 to $100,000 | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Income Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Income Unknown | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Insurance Medicaid | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Insurance Medicare | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Insurance Medicare + Medicaid | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Insurance Medicare + Private | 22 Participants | 0 Participants | 0 Participants | 10 Participants | 12 Participants |
| Insurance Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Insurance Private/commercial | 14 Participants | 0 Participants | 0 Participants | 7 Participants | 7 Participants |
| Insurance Private + Self Pay | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Insurance Self Pay/None | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Marital status Divorced | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Marital status Living with partner | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Marital status Married | 38 Participants | 0 Participants | 0 Participants | 16 Participants | 22 Participants |
| Marital status Never married | 9 Participants | 0 Participants | 0 Participants | 6 Participants | 3 Participants |
| Marital status Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Marital status Separated | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 12 Participants | 10 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 57 Participants | 13 Participants | 16 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Female | 74 Participants | 15 Participants | 18 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Male | 30 Participants | 11 Participants | 7 Participants | 7 Participants | 5 Participants |
| Single Item Literacy Screener Always | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Single Item Literacy Screener Never | 35 Participants | 0 Participants | 0 Participants | 16 Participants | 19 Participants |
| Single Item Literacy Screener Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
| Single Item Literacy Screener Often | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Single Item Literacy Screener Rarely | 13 Participants | 0 Participants | 0 Participants | 6 Participants | 7 Participants |
| Single Item Literacy Screener Sometimes | 4 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Study site Eskenazi Health | 66 Participants | 16 Participants | 17 Participants | 16 Participants | 17 Participants |
| Study site IU Health | 40 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants |
| Years caring for person with ADRD 1 year or less | 8 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Years caring for person with ADRD 2 years | 8 Participants | 0 Participants | 0 Participants | 5 Participants | 3 Participants |
| Years caring for person with ADRD 3 years | 11 Participants | 0 Participants | 0 Participants | 4 Participants | 7 Participants |
| Years caring for person with ADRD 4 years | 7 Participants | 0 Participants | 0 Participants | 4 Participants | 3 Participants |
| Years caring for person with ADRD 5 years | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Years caring for person with ADRD 6 years or more | 13 Participants | 0 Participants | 0 Participants | 7 Participants | 6 Participants |
| Years caring for person with ADRD Not measured | 53 Participants | 26 Participants | 27 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 | 1 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 | 0 / 27 | 0 / 26 |
Outcome results
Primary
Feasibility: BCN Acceptance (3 Months)
Acceptance 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.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Feasibility: BCN Acceptance (3 Months) | 2 score on a scale |
Primary
Feasibility: BCN Acceptance (6 Months)
Acceptance 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).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Feasibility: BCN Acceptance (6 Months) | 2.0 score on a scale |
Primary
Feasibility: BCN Usability (3 Months)
BCN 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).
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Feasibility: BCN Usability (3 Months) | 76.3 score on a scale |
Primary
Feasibility: BCN Usability (6 Months)
BCN 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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Feasibility: BCN Usability (6 Months) | 72.5 score on a scale |
Primary
Feasibility: Data Completeness
Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
Time frame: 6 months after enrollment and randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Feasibility: Data Completeness | 6 months | 22 Participants |
| All Participants | Feasibility: Data Completeness | 3 months | 19 Participants |
| Brain CareNotes (BCN) Software | Feasibility: Data Completeness | 6 months | 23 Participants |
| Brain CareNotes (BCN) Software | Feasibility: Data Completeness | 3 months | 21 Participants |
Primary
Feasibility: Recruitment Rate
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Time frame: 15 month accrual period
Population: Caregivers recruited to the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Feasibility: Recruitment Rate | 4.1 participants recruited per month | Standard Deviation 4.1 |
Secondary
Acute Care Utilization (3 Months)
Number of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention).
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Acute Care Utilization (3 Months) | Patients | 7 Participants |
| All Participants | Acute Care Utilization (3 Months) | Caregivers | 5 Participants |
| Brain CareNotes (BCN) Software | Acute Care Utilization (3 Months) | Patients | 13 Participants |
| Brain CareNotes (BCN) Software | Acute Care Utilization (3 Months) | Caregivers | 6 Participants |
Secondary
Acute Care Utilization (6 Months)
Number of all-cause hospital and emergency room admissions among patients and caregivers in the last 3 months (at 6 months post-intervention).
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Acute Care Utilization (6 Months) | Caregivers | 5 Participants |
| All Participants | Acute Care Utilization (6 Months) | Patients | 3 Participants |
| Brain CareNotes (BCN) Software | Acute Care Utilization (6 Months) | Caregivers | 3 Participants |
| Brain CareNotes (BCN) Software | Acute Care Utilization (6 Months) | Patients | 13 Participants |
Secondary
BPSD Severity (3 Months)
Severity 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).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | BPSD Severity (3 Months) | 18.3 score on a scale | Standard Deviation 15.1 |
| Brain CareNotes (BCN) Software | BPSD Severity (3 Months) | 12.4 score on a scale | Standard Deviation 11 |
Secondary
BPSD Severity (6 Months)
Severity 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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | BPSD Severity (6 Months) | 18.5 score on a scale | Standard Deviation 16 |
| Brain CareNotes (BCN) Software | BPSD Severity (6 Months) | 15.9 score on a scale | Standard Deviation 12.9 |
Secondary
BPSD Severity (Baseline)
Severity 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).
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | BPSD Severity (Baseline) | 17.2 score on a scale | Standard Deviation 15.5 |
| Brain CareNotes (BCN) Software | BPSD Severity (Baseline) | 16.4 score on a scale | Standard Deviation 13.4 |
Secondary
Caregiver Burden (3 Months)
Informal 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)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Caregiver Burden (3 Months) | 10.9 score on a scale | Standard Deviation 8.2 |
| Brain CareNotes (BCN) Software | Caregiver Burden (3 Months) | 7.5 score on a scale | Standard Deviation 6.8 |
Secondary
Caregiver Burden (6 Months)
Informal 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)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Caregiver Burden (6 Months) | 8.8 score on a scale | Standard Deviation 7 |
| Brain CareNotes (BCN) Software | Caregiver Burden (6 Months) | 7.8 score on a scale | Standard Deviation 6.2 |
Secondary
Caregiver Burden (Baseline)
Informal 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)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Caregiver Burden (Baseline) | 9.8 score on a scale | Standard Deviation 7.4 |
| Brain CareNotes (BCN) Software | Caregiver Burden (Baseline) | 8.5 score on a scale | Standard Deviation 6.3 |