Dementia
Conditions
Keywords
dementia, pragmatic clinical trial, effectiveness, cost-effectiveness, Alzheimer's disease
Brief summary
D-CARE: The Dementia Care Study This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker, nurse, or therapist) who works at a Community-Based Organization (CBO). The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.
Detailed description
D-CARE: The Dementia Care Study Objective: To determine the comparative effectiveness and cost-effectiveness of two evidence-based models of comprehensive dementia care, as well as the effectiveness and cost-effectiveness of both models versus usual care. Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the patient/caregiver dyad. Duration: 6.5 years. This includes 34 months for recruitment of study participants, 18 months of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.
Interventions
OTHERHealth System-based Dementia Care
Active comparator
OTHERCommunity-based Dementia Care
Active comparator
OTHERUsual Care
Control
Sponsors
Patient-Centered Outcomes Research Institute
National Institute on Aging (NIA)
Yale University
Benjamin Rose Institute on Aging
Baylor Scott and White Health
Wake Forest University Health Sciences
University of Texas
Geisinger Clinic
University of Oklahoma
RAND
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
* 2150 dyads of persons with dementia and their respective primary caregiver * 1000 in each intervention arm, and 150 in the usual care arm
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The person with dementia has a diagnosis of dementia established by a physician or other primary care provider * The person with dementia has a primary care provider who is willing to partner with the study * The person with dementia has a caregiver who speaks English or Spanish, and has a phone * Persons living with dementia in assisted living facilities will be eligible if they do not meet any
Exclusion criteria
(however, no more than 25% of participants can be living in assisted living facilities at the time of enrollment. This will be monitored when the first 25% of the sample has been enrolled.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Dementia-related Behavioral Symptoms | Baseline | The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline. |
| Severity of Dementia-related Behavioral Symptoms (Common Baseline) | Baseline | The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm. |
| Caregiver Distress/Strain | Baseline | The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline. |
| Caregiver Distress/Strain (Common Baseline) | Baseline | The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Self-Efficacy: 4-item Self-efficacy Scale | Baseline | Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline. |
| Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | Baseline | Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline. |
| Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline) | Baseline | Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6 and 18 months least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm. |
| Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline) | Baseline | Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm. |
| Severity of Depression in Caregivers | Baseline | The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline. |
| Severity of Depression in Caregivers (Common Baseline) | Baseline | The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit | 18 months | Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-Q severity scale is defined as having a 1-year score of less than or equal to 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of less than or equal to 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program. The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months. |
| Quality of Life of People With Dementia: QOL-AD | 18 months | Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers. It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three. The outcome will be measured at 18 months. |
| Positive Aspects of Family Caregiving | 6 months | The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience. The outcome will be measured at 6 months. |
| Inpatient Days Spent at an Acute Care Hospital | 18 months | Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS). |
| Inpatient Days Spent at an Inpatient Rehabilitation Facility | 18 months | Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS. |
| Inpatient Days Spent at a Skilled Nursing Facility | 18 months | Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS. |
| Cognition of Persons Living With Dementia | Baseline | Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study at 18 months to document disease progression. To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Higher scores indicate less impairment. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent. This entry presents the means of the raw outcome data for each arm among PLWD who completed MoCA at baseline. |
| Placement in Long-term Care Facility | 18 months | Placement in a Long-term Care Facility is defined by (1) observed placement in a long-term care facility, or (2) the time (days) from enrollment to when individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS. |
| Days Spent Receiving Hospice Benefit | 18 months | Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS. |
| Physician Assessment of Dementia Care at 18 Months | 18 months | The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program. Each item will be examined individually (with the range of each item differing). The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study. All providers with at least one enrolled patient in the study will be surveyed. |
| Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms | 18 months | The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity. Thus, the ratio will be the net costs per unit change in NPI-Q-Severity. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites. |
| Cost-Effectiveness Relative to Caregiver Distress | 18 months | The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI). Thus, the ratio will be the net costs per unit change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites. |
| Inpatient Days Spent at a Long-term Care Facility | 18 months | Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS. |
| Cognition of Persons Living With Dementia (Missing Data) | Baseline | Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression. To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent. Report is among PLWD with missing MoCA at baseline. |
| Functional Status Measured by FAQ | Baseline | Functional status measured using the Functional Activities Questionnaire (FAQ). FAQ ranges from 0 to 30 with higher scores indicating more functional dependence. FAQ outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline. |
| Functional Status Measured by ADLs | Baseline | Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence. Outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline. |
| Goal Attainment | 18 months | Asks patients & caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention. Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS). GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2). Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months. |
| Number of Persons With Dementia That Die Over the Course of the Study | 18 months | Mortality of persons with dementia as measured by interviews with caregivers at 3, 6, 12, and 18 months. Data will be verified using the Center for Medicare and Medicaid Services at 18 months. For participants who did not complete the 18-month interview, vital status will be investigated using the electronic health records (EHR). |
| Time Spent at Home | 18 months | Time spent at home is defined as \[number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization\]. |
| Caregiver Rating of Dementia Care Quality | 12 months | Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures. The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality). |
| Caregiver Assessment of Dementia Care | 18 months | Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program). The questionnaire will be administered at 3, 12 and 18 months. |
| Dementia Burden (Caregiver) | 18 months | Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 points. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months. |
Countries
United States
Participant flow
Recruitment details
Participants were referred by physicians or self-referred at 4 clinical trial sites (2 academic, 2 community-based) in 3 states. 2,176 PLwD/caregiver dyads were enrolled between June 2019 and January 2022.
Pre-assignment details
Of 11,652 referred for screening, 156 were not screened due to recruitment ending, 2,929 could not be screened, 290 were unable to complete the baseline interview, 3,415 met exclusion criteria, and 2,686 declined participation.
Participants by arm
| Arm | Count |
|---|---|
| Health Systems-Based Dementia Care Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program.
Health System-based Dementia Care: Active comparator | 1,016 |
| Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program.
Community-based Dementia Care: Active comparator | 1,016 |
| Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800-3900 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services.
Usual Care: Control | 144 |
| Total | 2,176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 254 | 223 | 37 |
| Overall Study | Lost to Follow-up | 63 | 50 | 15 |
| Overall Study | Withdrawal by Subject | 99 | 81 | 11 |
Baseline characteristics
| Characteristic | Community-Based Dementia Care | Usual Care | Health Systems-Based Dementia Care | Total |
|---|---|---|---|---|
| Age, Continuous Caregiver Age | 65.6 years STANDARD_DEVIATION 12.3 | 66.2 years STANDARD_DEVIATION 11.7 | 64.8 years STANDARD_DEVIATION 12.3 | 65.2 years STANDARD_DEVIATION 12.3 |
| Age, Continuous PLWD Age | 80.6 years STANDARD_DEVIATION 8.7 | 81.0 years STANDARD_DEVIATION 8.4 | 80.6 years STANDARD_DEVIATION 8.3 | 80.6 years STANDARD_DEVIATION 8.5 |
| Caregiver Education Graduated from college | 327 Participants | 46 Participants | 302 Participants | 675 Participants |
| Caregiver Education Graduate or professional degree | 196 Participants | 32 Participants | 200 Participants | 428 Participants |
| Caregiver Education HS graduate or GED | 164 Participants | 22 Participants | 172 Participants | 358 Participants |
| Caregiver Education Less than HS graduate | 28 Participants | 1 Participants | 39 Participants | 68 Participants |
| Caregiver Education Some college or equivalent | 301 Participants | 43 Participants | 303 Participants | 647 Participants |
| Caregiver Education Unknown or not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Caregiver living with PLWD No | 261 Participants | 39 Participants | 287 Participants | 587 Participants |
| Caregiver living with PLWD Unknown or not reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Caregiver living with PLWD Yes | 755 Participants | 105 Participants | 728 Participants | 1588 Participants |
| Caregiver Marital Status Divorced | 98 Participants | 13 Participants | 97 Participants | 208 Participants |
| Caregiver Marital Status Married/Partner | 799 Participants | 118 Participants | 780 Participants | 1697 Participants |
| Caregiver Marital Status Other | 8 Participants | 3 Participants | 9 Participants | 20 Participants |
| Caregiver Marital Status Single | 84 Participants | 9 Participants | 105 Participants | 198 Participants |
| Caregiver Marital Status Widowed | 27 Participants | 1 Participants | 25 Participants | 53 Participants |
| Caregiver Primary Language English | 1004 Participants | 144 Participants | 1011 Participants | 2159 Participants |
| Caregiver Primary Language Spanish | 12 Participants | 0 Participants | 5 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 87 Participants | 14 Participants | 90 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 922 Participants | 128 Participants | 919 Participants | 1983 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Persons Living with Dementia (PLWD) Primary Language English | 995 Participants | 142 Participants | 999 Participants | 2136 Participants |
| Persons Living with Dementia (PLWD) Primary Language Spanish | 21 Participants | 2 Participants | 17 Participants | 40 Participants |
| PLWD Education Graduated from college | 168 Participants | 21 Participants | 206 Participants | 395 Participants |
| PLWD Education Graduate or professional degree | 144 Participants | 20 Participants | 136 Participants | 300 Participants |
| PLWD Education HS graduate or GED | 312 Participants | 48 Participants | 267 Participants | 627 Participants |
| PLWD Education Less than HS graduate | 154 Participants | 18 Participants | 167 Participants | 339 Participants |
| PLWD Education Some college or equivalent | 238 Participants | 35 Participants | 238 Participants | 511 Participants |
| PLWD Education Unknown or not reported | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| PLWD Living Arrangement Assisted Living Facility | 50 Participants | 9 Participants | 57 Participants | 116 Participants |
| PLWD Living Arrangement At home alone without caregiver | 130 Participants | 21 Participants | 139 Participants | 290 Participants |
| PLWD Living Arrangement At home with caregiver | 753 Participants | 105 Participants | 723 Participants | 1581 Participants |
| PLWD Living Arrangement At home with someone else | 83 Participants | 9 Participants | 97 Participants | 189 Participants |
| PLWD Marital Status Divorced | 97 Participants | 12 Participants | 99 Participants | 208 Participants |
| PLWD Marital Status Married/Partner | 546 Participants | 78 Participants | 547 Participants | 1171 Participants |
| PLWD Marital Status Other | 5 Participants | 0 Participants | 8 Participants | 13 Participants |
| PLWD Marital Status Single | 22 Participants | 3 Participants | 40 Participants | 65 Participants |
| PLWD Marital Status Widowed | 346 Participants | 51 Participants | 322 Participants | 719 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 0 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 115 Participants | 20 Participants | 121 Participants | 259 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 5 Participants | 18 Participants | 43 Participants |
| Race (NIH/OMB) White | 872 Participants | 119 Participants | 855 Participants | 1839 Participants |
| Region of Enrollment United States | 1016 dyads | 144 dyads | 1016 dyads | 2176 dyads |
| Sex: Female, Male Caregiver Sex Female | 760 Participants | 118 Participants | 772 Participants | 1650 Participants |
| Sex: Female, Male Caregiver Sex Male | 256 Participants | 26 Participants | 244 Participants | 526 Participants |
| Sex: Female, Male PLWD Sex Female | 583 Participants | 77 Participants | 611 Participants | 1271 Participants |
| Sex: Female, Male PLWD Sex Male | 433 Participants | 67 Participants | 405 Participants | 905 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 254 / 1,016 | 223 / 1,016 | 37 / 144 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 528 / 1,016 | 533 / 1,016 | 70 / 144 |
Outcome results
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 11.03 score on a scale | Standard Error 0.2 |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.65 score on a scale | Standard Error 0.19 |
| Usual Care | Caregiver Distress/Strain | 11.13 score on a scale | Standard Error 0.55 |
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents those average least squares means across all follow-up times for each arm.
Time frame: Average of 3M, 6M, 12M, and 18M least square means
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 10.74 score on a scale |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.50 score on a scale |
| Usual Care | Caregiver Distress/Strain | 10.60 score on a scale |
p-value: 0.5497.5% CI: [-0.16, 0.66]Mixed Models Analysis
p-value: 0.7997.5% CI: [-0.94, 0.74]Mixed Models Analysis
p-value: 0.7997.5% CI: [-0.7, 0.99]Mixed Models Analysis
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 18 months.
Time frame: 18-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 11.26 score on a scale | Standard Error 0.26 |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.64 score on a scale | Standard Error 0.24 |
| Usual Care | Caregiver Distress/Strain | 10.32 score on a scale | Standard Error 0.72 |
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 12 months.
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 11.00 score on a scale | Standard Error 0.24 |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.50 score on a scale | Standard Error 0.24 |
| Usual Care | Caregiver Distress/Strain | 10.41 score on a scale | Standard Error 0.69 |
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 6 months.
Time frame: 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 10.61 score on a scale | Standard Error 0.23 |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.26 score on a scale | Standard Error 0.22 |
| Usual Care | Caregiver Distress/Strain | 10.53 score on a scale | Standard Error 0.65 |
Primary
Caregiver Distress/Strain
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 3 months.
Time frame: 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain | 10.52 score on a scale | Standard Error 0.22 |
| Community-Based Dementia Care | Caregiver Distress/Strain | 10.01 score on a scale | Standard Error 0.2 |
| Usual Care | Caregiver Distress/Strain | 10.00 score on a scale | Standard Error 0.53 |
Primary
Caregiver Distress/Strain (Common Baseline)
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Distress/Strain (Common Baseline) | 10.61 score on a scale |
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 12 months.
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.58 score on a scale | Standard Error 0.27 |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.14 score on a scale | Standard Error 0.25 |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 9.95 score on a scale | Standard Error 0.74 |
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 10.32 score on a scale | Standard Error 0.22 |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.93 score on a scale | Standard Error 0.21 |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 10.42 score on a scale | Standard Error 0.56 |
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 18 months.
Time frame: 18-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.80 score on a scale | Standard Error 0.29 |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.51 score on a scale | Standard Error 0.27 |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 9.60 score on a scale | Standard Error 0.79 |
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents those average least squares means across all follow-up times for each arm.
Time frame: Average of 3M, 6M, 12M, and 18M least square means.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.79 score on a scale |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.50 score on a scale |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 10.12 score on a scale |
p-value: 0.3397.5% CI: [-0.18, 0.78]Mixed Models Analysis
p-value: 0.3397.5% CI: [-1.61, 0.37]Mixed Models Analysis
p-value: 0.4697.5% CI: [-1.32, 0.67]Mixed Models Analysis
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 6 months.
Time frame: 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.41 score on a scale | Standard Error 0.25 |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 8.78 score on a scale | Standard Error 0.23 |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 9.93 score on a scale | Standard Error 0.68 |
Primary
Severity of Dementia-related Behavioral Symptoms
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 3 month.
Time frame: 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 9.10 score on a scale | Standard Error 0.24 |
| Community-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms | 8.98 score on a scale | Standard Error 0.22 |
| Usual Care | Severity of Dementia-related Behavioral Symptoms | 9.67 score on a scale | Standard Error 0.65 |
Primary
Severity of Dementia-related Behavioral Symptoms (Common Baseline)
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Severity of Dementia-related Behavioral Symptoms (Common Baseline) | 10.07 score on a scale |
Secondary
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 6 months.
Time frame: 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.01 score on a scale | Standard Error 0.1 |
| Community-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.00 score on a scale | Standard Error 0.1 |
| Usual Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 14.29 score on a scale | Standard Error 0.32 |
Secondary
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents those average least squares means across all follow-up times for each arm.
Time frame: Average of 6M and 18M least square means
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.06 score on a scale |
| Community-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.22 score on a scale |
| Usual Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 14.36 score on a scale |
p-value: 0.6295% CI: [-0.37, 0.06]Mixed Models Analysis
p-value: 0.0195% CI: [0.26, 1.14]Mixed Models Analysis
p-value: 0.00195% CI: [0.42, 1.29]Mixed Models Analysis
Secondary
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 18 months.
Time frame: 18-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.09 score on a scale | Standard Error 0.11 |
| Community-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 15.36 score on a scale | Standard Error 0.11 |
| Usual Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 14.66 score on a scale | Standard Error 0.35 |
Secondary
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 13.26 score on a scale | Standard Error 0.1 |
| Community-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 13.12 score on a scale | Standard Error 0.1 |
| Usual Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale | 13.17 score on a scale | Standard Error 0.25 |
Secondary
Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale \[range, 1 (strongly disagree) to 5 (strongly agree)\] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6 and 18 months least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline) | 13.24 score on a scale |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 18 months.
Time frame: 18-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.12 score on a scale | Standard Error 0.43 |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.80 score on a scale | Standard Error 0.4 |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.53 score on a scale | Standard Error 1.12 |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents those average least squares means across all follow-up times for each arm.
Time frame: Average of 3M, 6M, 12M, and 18M least square means
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.29 score on a scale |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.77 score on a scale |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 13.10 score on a scale |
p-value: 0.4895% CI: [-0.09, 1.13]Mixed Models Analysis
p-value: 0.6295% CI: [-2.07, 0.45]Mixed Models Analysis
p-value: 0.2395% CI: [-2.58, -0.07]Mixed Models Analysis
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 12 months.
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.09 score on a scale | Standard Error 0.39 |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.76 score on a scale | Standard Error 0.37 |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.63 score on a scale | Standard Error 1.02 |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.96 score on a scale | Standard Error 0.32 |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.66 score on a scale | Standard Error 0.31 |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.69 score on a scale | Standard Error 0.79 |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 3 months.
Time frame: 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.45 score on a scale | Standard Error 0.35 |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.15 score on a scale | Standard Error 0.32 |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.42 score on a scale | Standard Error 0.91 |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 6 months.
Time frame: 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.88 score on a scale | Standard Error 0.37 |
| Community-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 11.23 score on a scale | Standard Error 0.34 |
| Usual Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms | 12.62 score on a scale | Standard Error 0.95 |
Secondary
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline) | 12.62 score on a scale |
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents those average least squares means across all follow-up times for each arm.
Time frame: Average of 3M, 6M, 12M, and 18M least square means
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.70 score on a scale |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.42 score on a scale |
| Usual Care | Severity of Depression in Caregivers | 4.69 score on a scale |
p-value: 0.2395% CI: [0.01, 0.54]Mixed Models Analysis
p-value: 0.9895% CI: [-0.53, 0.55]Mixed Models Analysis
p-value: 0.6595% CI: [-0.81, 0.27]Mixed Models Analysis
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 18 months.
Time frame: 18-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.34 score on a scale | Standard Error 0.18 |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.39 score on a scale | Standard Error 0.17 |
| Usual Care | Severity of Depression in Caregivers | 4.19 score on a scale | Standard Error 0.43 |
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.72 score on a scale | Standard Error 0.15 |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.78 score on a scale | Standard Error 0.15 |
| Usual Care | Severity of Depression in Caregivers | 5.17 score on a scale | Standard Error 0.4 |
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 12 months.
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.46 score on a scale | Standard Error 0.17 |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.41 score on a scale | Standard Error 0.17 |
| Usual Care | Severity of Depression in Caregivers | 4.66 score on a scale | Standard Error 0.48 |
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 6 months.
Time frame: 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.55 score on a scale | Standard Error 0.16 |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.26 score on a scale | Standard Error 0.15 |
| Usual Care | Severity of Depression in Caregivers | 4.57 score on a scale | Standard Error 0.42 |
Secondary
Severity of Depression in Caregivers
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the means of the raw outcome data for each arm at 3 months.
Time frame: 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers | 4.47 score on a scale | Standard Error 0.16 |
| Community-Based Dementia Care | Severity of Depression in Caregivers | 4.40 score on a scale | Standard Error 0.15 |
| Usual Care | Severity of Depression in Caregivers | 4.68 score on a scale | Standard Error 0.41 |
Secondary
Severity of Depression in Caregivers (Common Baseline)
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores \>10 indicating moderate symptoms and scores \>20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common treatment 0. This entry presents the least squares mean of the baseline treatment 0, which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Health Systems-Based Dementia Care | Severity of Depression in Caregivers (Common Baseline) | 4.72 score on a scale |
Other Pre-specified
Caregiver Assessment of Dementia Care
Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program). The questionnaire will be administered at 3, 12 and 18 months.
Time frame: 18 months
Other Pre-specified
Caregiver Rating of Dementia Care Quality
Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures. The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality).
Time frame: 12 months
Other Pre-specified
Clinical Benefit
Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-Q severity scale is defined as having a 1-year score of less than or equal to 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of less than or equal to 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program. The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months.
Time frame: 18 months
Other Pre-specified
Cognition of Persons Living With Dementia
Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study at 18 months to document disease progression. To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Higher scores indicate less impairment. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent. This entry presents the means of the raw outcome data for each arm among PLWD who completed MoCA at baseline.
Time frame: Baseline
Population: PLWD with completed MoCA at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Cognition of Persons Living With Dementia | 6.2 score on a scale | Standard Deviation 5.7 |
| Community-Based Dementia Care | Cognition of Persons Living With Dementia | 6.4 score on a scale | Standard Deviation 6 |
| Usual Care | Cognition of Persons Living With Dementia | 5.9 score on a scale | Standard Deviation 5.1 |
Other Pre-specified
Cognition of Persons Living With Dementia (Missing Data)
Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression. To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent. Report is among PLWD with missing MoCA at baseline.
Time frame: Baseline
Population: PLWD with missing MoCA at baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Systems-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Hearing impairment | 115 Participants |
| Health Systems-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Partial data | 20 Participants |
| Health Systems-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Clinical decision | 52 Participants |
| Health Systems-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Participant refusal | 125 Participants |
| Community-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Participant refusal | 131 Participants |
| Community-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Clinical decision | 39 Participants |
| Community-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Partial data | 16 Participants |
| Community-Based Dementia Care | Cognition of Persons Living With Dementia (Missing Data) | Hearing impairment | 121 Participants |
| Usual Care | Cognition of Persons Living With Dementia (Missing Data) | Partial data | 2 Participants |
| Usual Care | Cognition of Persons Living With Dementia (Missing Data) | Hearing impairment | 15 Participants |
| Usual Care | Cognition of Persons Living With Dementia (Missing Data) | Clinical decision | 7 Participants |
| Usual Care | Cognition of Persons Living With Dementia (Missing Data) | Participant refusal | 21 Participants |
Other Pre-specified
Cost-Effectiveness Relative to Caregiver Distress
The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI). Thus, the ratio will be the net costs per unit change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.
Time frame: 18 months
Other Pre-specified
Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms
The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity. Thus, the ratio will be the net costs per unit change in NPI-Q-Severity. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.
Time frame: 18 months
Other Pre-specified
Days Spent Receiving Hospice Benefit
Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.
Time frame: 18 months
Other Pre-specified
Dementia Burden (Caregiver)
Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 points. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
Time frame: 18 months
Other Pre-specified
Functional Status Measured by ADLs
Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence. Outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
Population: PLWD with completed Katz at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Functional Status Measured by ADLs | 4.4 score on a scale | Standard Deviation 1.9 |
| Community-Based Dementia Care | Functional Status Measured by ADLs | 4.5 score on a scale | Standard Deviation 1.8 |
| Usual Care | Functional Status Measured by ADLs | 4.5 score on a scale | Standard Deviation 1.8 |
Other Pre-specified
Functional Status Measured by FAQ
Functional status measured using the Functional Activities Questionnaire (FAQ). FAQ ranges from 0 to 30 with higher scores indicating more functional dependence. FAQ outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline.
Time frame: Baseline
Population: PLWD with completed FAQ at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-Based Dementia Care | Functional Status Measured by FAQ | 21.4 score on a scale | Standard Deviation 7.5 |
| Community-Based Dementia Care | Functional Status Measured by FAQ | 21.3 score on a scale | Standard Deviation 7.2 |
| Usual Care | Functional Status Measured by FAQ | 21.0 score on a scale | Standard Deviation 8 |
Other Pre-specified
Goal Attainment
Asks patients & caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention. Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS). GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2). Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.
Time frame: 18 months
Other Pre-specified
Inpatient Days Spent at a Long-term Care Facility
Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.
Time frame: 18 months
Other Pre-specified
Inpatient Days Spent at an Acute Care Hospital
Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS).
Time frame: 18 months
Other Pre-specified
Inpatient Days Spent at an Inpatient Rehabilitation Facility
Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.
Time frame: 18 months
Other Pre-specified
Inpatient Days Spent at a Skilled Nursing Facility
Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.
Time frame: 18 months
Other Pre-specified
Number of Persons With Dementia That Die Over the Course of the Study
Mortality of persons with dementia as measured by interviews with caregivers at 3, 6, 12, and 18 months. Data will be verified using the Center for Medicare and Medicaid Services at 18 months. For participants who did not complete the 18-month interview, vital status will be investigated using the electronic health records (EHR).
Time frame: 18 months
Other Pre-specified
Physician Assessment of Dementia Care at 18 Months
The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program. Each item will be examined individually (with the range of each item differing). The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study. All providers with at least one enrolled patient in the study will be surveyed.
Time frame: 18 months
Other Pre-specified
Placement in Long-term Care Facility
Placement in a Long-term Care Facility is defined by (1) observed placement in a long-term care facility, or (2) the time (days) from enrollment to when individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.
Time frame: 18 months
Other Pre-specified
Positive Aspects of Family Caregiving
The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience. The outcome will be measured at 6 months.
Time frame: 6 months
Other Pre-specified
Quality of Life of People With Dementia: QOL-AD
Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers. It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three. The outcome will be measured at 18 months.
Time frame: 18 months
Other Pre-specified
Time Spent at Home
Time spent at home is defined as \[number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization\].
Time frame: 18 months