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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG062966 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC Clinical Program Only and Usual Care | Active Comparator | Patients and informal caregivers randomized to the comparison group will receive care provided by the ABC Clinical Program and IUHP. The ABC Clinical Program is the standard of ADRD care at Eskenazi Health and Primary Care Visits at Indiana University Health is the usual care. |
|
| BCN Mobile App Plus ABC and BCN Mobile app only | Experimental | Patients and caregivers randomized to the intervention group will continue to receive care in ABC clinical program and IUHP, and have the BCN software installed on either the caregiver's personal mobile device (assuming it meets minimal technical requirements) or a device provided by the study, per participant preference. A research assistant will orient participants to the device, provide training on the BCN software, and troubleshoot technical issues. Participants will receive daytime technical support by phone, electronic support request through a separate app, or printed and in-app help manuals. Hardware, software, and connectivity check-ups will be provided by study research personnel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC Clinical Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment Rate | Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period. | 15 month accrual period |
| Feasibility: Data Completeness | Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months. | 6 months after enrollment and randomization |
| 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). | 3 months |
| 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. | 6 months |
| 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. | 3 months |
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline |
| Caregiver Burden (3 Months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard J. Holden, PhD | Indiana University | Principal Investigator |
| Malaz Boustani, MD, MPH | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| IU Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33431027 | Derived | Braly T, Muriathiri D, Brown JC, Taylor BM, Boustani MA, Holden RJ. Technology intervention to support caregiving for Alzheimer's disease (I-CARE): study protocol for a randomized controlled pilot trial. Pilot Feasibility Stud. 2021 Jan 11;7(1):23. doi: 10.1186/s40814-020-00755-2. |
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Data, or results, will be shared through traditional mechanisms such as peer-reviewed journals and presentations at national meetings. The Enhanced Medical Record - Aging Brain Care (eMR-ABC), the dedicated electronic medical record for the Aging Brain Care (ABC) Clinical Program, was developed with the intent of sharing de-identified data with the scientific community. The Indiana Network for Patient Care (INPC) is a state-wide health information exchange. INPC data is collected for patient care purposes and is not "owned" by Indiana University or the Regenstrief Institute, Inc. - each participating health care system or program retains ownership of their data. At present, Indiana University/Regenstrief Institute scientists do not have the direct authority to share even de-identified patient data. Therefore, any request to use these data for research purposes must be adjudicated on a case-by-case basis.
10 years from the completion of the study
To obtain IDP, requesters must provide a CV or biosketch detailing their institutional affiliation(s), the scientific purpose for the data sharing request, and plans for the safe and secure management of deidentified study data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age unknown for 4 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Recruitment Rate | Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period. | Caregivers recruited to the study | Posted | Mean | Standard Deviation | participants recruited per month | 15 month accrual period |
|
|
6 months from enrollment
Adverse events among caregiver participants were collected and reported separately from patient participants
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care - Caregivers | Informal caregivers 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. |
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Not provided
BCN usage (a primary feasibility outcome) continues to be analyzed and data are not reported.
Data are reported from consented informal caregivers only. Caregivers provided data on themselves and the patient.
Data on secondary outcomes of Caregiver Burden and Patient Symptom Severity were imputed for all randomized participants.
Acute care utilization data combine emergency room (ER) and hospital based admissions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Holden | Indiana University | 812-586-1965 | rjholden@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2020 | Apr 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2020 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Not provided
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|
|
| BCN | Behavioral | 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:
|
|
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) |
| 3 months |
| 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) | 6 months |
| 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). | baseline |
| 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). | 3 months |
| 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). | 6 months |
| 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). | 3 months |
| 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). | 6 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Lost to Follow-up |
|
| BG001 | 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:
|
| BG002 | 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. |
| BG003 | 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:
|
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex unknown for 2 participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Caregiver living situation | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Years caring for person with ADRD | Count of Participants | Participants |
|
| Hours per day spent caregiving | Count of Participants | Participants |
|
| Single Item Literacy Screener | Participants were asked to rate their need for help reading heath information on a five-point scale (Never, Rarely, Sometimes, Often, Always) | Count of Participants | Participants |
|
| Study site | Count of Participants | Participants |
|
|
| Primary | Feasibility: Data Completeness | Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months. | Posted | Count of Participants | Participants | 6 months after enrollment and randomization |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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). | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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). | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Brain CareNotes (BCN) Software - Caregivers | 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:
| 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Usual Care - Patients | 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. | 1 | 27 | 0 | 27 | 0 | 27 |
| EG003 | Brain CareNotes (BCN) Software - Patients | 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:
| 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Living with partner |
|
| Divorced |
|
| Separated |
|
| Never married |
|
| Not measured |
|
| Lives with children's family |
|
| Lives with spouse and children's family |
|
| Lives alone |
|
| Other |
|
| Not measured |
|
| Medicaid |
|
| Medicare + Medicaid |
|
| Private/commercial |
|
| Medicare + Private |
|
| Self Pay/None |
|
| Private + Self Pay |
|
| Not measured |
|
| Employed part time (less than 40 hours) |
|
| Unemployed |
|
| Retired |
|
| Homemaker |
|
| On social security or disability |
|
| Not measured |
|
| $10,001 to $30,000 |
|
| $30,001 to $50,000 |
|
| $50,001 to $75,000 |
|
| $75,001 to $100,000 |
|
| $100,001 or above |
|
| Unknown |
|
| Not measured |
|
| Some High School |
|
| High School Graduate or GED |
|
| Some College |
|
| College Degree |
|
| Masters or other advanced degree |
|
| Unknown |
|
| Not measured |
|
| 2 years |
|
| 3 years |
|
| 4 years |
|
| 5 years |
|
| 6 years or more |
|
| Not measured |
|
| 2-5 hours |
|
| 6-9 hours |
|
| 10-13 hours |
|
| 14-17 hours |
|
| 18+ hours |
|
| Not measured |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Always |
|
| Not measured |
|
| IU Health |
|