Health System-based Dementia Care
OtherActive comparator
NCT Number: NCT03786471
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.
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Interventional
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Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active comparator
Active comparator
Control
Time frame: 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.
Time frame: 3-month
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: 6-month
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: 12-month
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: 18-month
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: 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: Average of 3M, 6M, 12M, and 18M least square means.
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: 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.
Time frame: 3-month
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: 6-month
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: 12-month
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: 18-month
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: 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: Average of 3M, 6M, 12M, and 18M least square means
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: 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.
Time frame: 3-month
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: 6-month
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: 12-month
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: 18-month
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: 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: Average of 3M, 6M, 12M, and 18M least square means
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: 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.
Time frame: 3-month
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: 6-month
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: 12-month
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: 18-month
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: 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: Average of 3M, 6M, 12M, and 18M least square means
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: 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.
Time frame: 6-month
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: 18-month
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: 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: Average of 6M and 18M least square means
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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].
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
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.
University of California, Los Angeles
Other
Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
Acronym: D-CARE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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