DementiaD-CARENCT03786471

D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care

A study testing Health System-based Dementia Care and Community-based Dementia Care in people with Dementia, run by University of California, Los Angeles at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Dementia
What is being tested?: Health System-based Dementia Care and Community-based Dementia Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,176 participants
Where: 4 sitesUnited States
Study dates: 28 Jun 2019to 21 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.)

Who cannot join

The person with dementia resides in a nursing home at the time of recruitment
The person with dementia is enrolled in hospice at the time of screen
The person with dementia plans to move out of the area within the coming year
The caregiver of the person with dementia is unwilling or anticipates being incapable of providing self-reported outcome measures for 18 months
Baseline measures refused or not completed
The caregiver is paid, and is not a relative or close friend of the person with dementia

Show all 10Show fewer

At telephone or in-person screener, the caregiver has cognitive impairment
The person with dementia or caregiver is participating in another dementia intervention study
Patients and caregivers who are members of a sites' Local Patient \& Stakeholder Committee
There is already a member of the same household participating in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Texas Medical Branch
Galveston, Texas, 77555
Baylor Scott & White
Temple, Texas, 76508
Geisinger Health
Wilkes-Barre, Pennsylvania, 18765
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care

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.

Read the 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.

Conditions: Dementia
Being tested: Health System-based Dementia Care, Community-based Dementia Care, Usual Care
Keywords: dementia, pragmatic clinical trial, effectiveness, cost-effectiveness, Alzheimer's disease
Medical subject headings: Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health System-based Dementia CareOther
Active comparator
Community-based Dementia CareOther
Active comparator
Usual CareOther
Control

Study groups in NCT03786471
Study group	Role	What they receive
Health Systems-Based Dementia Care	Active comparator	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. Receives: Other: Health System-based Dementia Care
Community-Based Dementia Care	Active comparator	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. Receives: Other: Community-based Dementia Care
Usual Care	Other	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 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. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: 3-month
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.
Measured: 6-month
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.
Measured: 12-month
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.
Measured: 18-month
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.
Measured: Baseline
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.
Measured: Average of 3M, 6M, 12M, and 18M least square means.
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.
Measured: Baseline
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.
Measured: 3-month
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.
Measured: 6-month
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.
Measured: 12-month
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.
Measured: 18-month
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.
Measured: Baseline
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.
Measured: Average of 3M, 6M, 12M, and 18M least square means

Secondary outcomes (19)

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.
Measured: Baseline
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.
Measured: 3-month
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.
Measured: 6-month
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.
Measured: 12-month
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.
Measured: 18-month
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.
Measured: Baseline
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.
Measured: Average of 3M, 6M, 12M, and 18M least square means
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.
Measured: Baseline
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.
Measured: 3-month
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.
Measured: 6-month
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.
Measured: 12-month
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.
Measured: 18-month
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.
Measured: Baseline
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.
Measured: Average of 3M, 6M, 12M, and 18M least square means
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.
Measured: Baseline
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.
Measured: 6-month
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.
Measured: 18-month
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.
Measured: Baseline
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.
Measured: Average of 6M and 18M least square means

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201921 Aug 2023

First posted26 Dec 2018
Study start28 Jun 2019
Primary completion21 Aug 2023
Study completion21 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DementiaStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 2,176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03786471
Sponsor's protocol ID: IRB 18-001796
Other IDs: R01AG061078-01, PCS-2017C1-6534
Acronym: D-CARE
Status last verified: Jan 2025
First submitted: 17 Dec 2018
Last updated: 30 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Reuben DB, Stevens AB, Gill TM, Yang M, Volpi E, Lichtenstein ML, Jennings LA, Galloway R, Summapund J, Araujo K, Oyeyemi DM, Cho J, Xu Y, Peduzzi P, Greene EJ. Correlates and predictors of self-efficacy among dementia caregivers: D-CARE findings. Alzheimers Dement. 2026 Jul;22(7):e71636. doi: 10.1002/alz.71636.
PubMed 42386685
Oyeyemi DM, Greene EJ, Xu Y, Lee DR, Samper-Ternent R, Lichtenstein ML, Stevens A, Williamson JD, Karlamangla AS, Saliba D, Reuben DB. Self-efficacy change among diverse family caregivers in dementia care. J Gerontol B Psychol Sci Soc Sci. 2026 Jan 12;81(2):gbaf233. doi: 10.1093/geronb/gbaf233.
PubMed 41243731
Reuben DB, Stevens AB, Gill TM, Williamson J, Volpi E, Lichtenstein ML, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson LC, Yang M, Green AS, Samper-Ternent R, Borek P, Xu Y, Peduzzi P, Greene EJ; D-CARE Study. Patient and Caregiver Outcomes of Health System, Community-Based, and Usual Dementia Care: A Prespecified Analysis of the Dementia Care Study (D-CARE) Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1227-1236. doi: 10.1001/jamainternmed.2025.4247.
PubMed 40892399
Reuben DB, Gill TM, Stevens A, Williamson J, Volpi E, Lichtenstein M, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson L, Yang M, Currie K, Green AS, Godoy S, Abraham S, Reese J, Samper-Ternent R, Hirst RM, Borek P, Charpentier P, Meng C, Dziura J, Xu Y, Skokos EA, He Z, Aiudi S, Peduzzi P, Greene EJ; D-CARE Study. Health System, Community-Based, or Usual Dementia Care for Persons With Dementia and Caregivers: The D-CARE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):950-961. doi: 10.1001/jama.2024.25056.
PubMed 39878968

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All Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
ClinicalTrials.gov ID: NCT03786471
Acronym / sponsor ID: D-CARE / IRB 18-001796
Conditions: Dementia
Keywords: dementia, pragmatic clinical trial, effectiveness, cost-effectiveness, Alzheimer's disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,176 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: 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
Study start: 28 Jun 2019 (actual)
Primary completion: 21 Aug 2023 (actual)
Study completion: 21 Aug 2023 (actual)
First posted: 26 Dec 2018 (actual)
Results: Posted 30 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

D-CARE: The Dementia Care Study

The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.

Detailed description

D-CARE: The Dementia Care Study

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
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

Arm	Type	Receives
Health Systems-Based Dementia Care	Active comparator	Other: Health System-based Dementia CareDementia 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.
Community-Based Dementia Care	Active comparator	Other: Community-based Dementia CareDementia 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.
Usual Care	Other	Other: Usual CareDementia 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 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.)

Key exclusion criteria (10 listed)

The person with dementia resides in a nursing home at the time of recruitment
The person with dementia is enrolled in hospice at the time of screen
The person with dementia plans to move out of the area within the coming year
The caregiver of the person with dementia is unwilling or anticipates being incapable of providing self-reported outcome measures for 18 months
Baseline measures refused or not completed

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health System-based Dementia CareActive comparator	Other	Health Systems-Based Dementia Care
Community-based Dementia CareActive comparator	Other	Community-Based Dementia Care
Usual CareControl	Other	Usual Care

Primary outcome

Severity of Dementia-related Behavioral Symptoms
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.
Severity of Dementia-related Behavioral Symptoms
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.
Severity of Dementia-related Behavioral Symptoms
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.
Severity of Dementia-related Behavioral Symptoms
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.
Severity of Dementia-related Behavioral Symptoms
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.
Severity of Dementia-related Behavioral Symptoms (Common Baseline)
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.
Severity of Dementia-related Behavioral Symptoms
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.
Caregiver Distress/Strain
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.
Caregiver Distress/Strain
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.
Caregiver Distress/Strain
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.
Caregiver Distress/Strain
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.
Caregiver Distress/Strain
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.
Caregiver Distress/Strain (Common Baseline)
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.
Caregiver Distress/Strain
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.

19 secondary outcomes

Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: Baseline
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: 3-month
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: 6-month
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: 12-month
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: 18-month
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)
Time frame: Baseline
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time frame: Average of 3M, 6M, 12M, and 18M least square means
Severity of Depression in Caregivers
Time frame: Baseline
Severity of Depression in Caregivers
Time frame: 3-month
Severity of Depression in Caregivers
Time frame: 6-month
Severity of Depression in Caregivers
Time frame: 12-month
Severity of Depression in Caregivers
Time frame: 18-month
Severity of Depression in Caregivers (Common Baseline)
Time frame: Baseline
Severity of Depression in Caregivers
Time frame: Average of 3M, 6M, 12M, and 18M least square means
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Time frame: Baseline
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Time frame: 6-month
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Time frame: 18-month
Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)
Time frame: Baseline
Caregiver Self-Efficacy: 4-item Self-efficacy Scale
Time frame: Average of 6M and 18M least square means

Results and safety

Results posted to the registry on 30 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Systems-Based Dementia Care	1,016	600
Community-Based Dementia Care	1,016	662
Usual Care	144	81

Primary outcome: Severity of Dementia-related Behavioral Symptoms

Time frame: Baseline. Mean (Standard Error). Unit: score on a scale

Measure	Health Systems-Based Dementia Care n = 992	Community-Based Dementia Care n = 990	Usual Care n = 140
Value	10.32 (0.22)	9.93 (0.21)	10.42 (0.56)

Primary outcome: Severity of Dementia-related Behavioral Symptoms

Time frame: 3-month. Mean (Standard Error). Unit: score on a scale

Measure	Health Systems-Based Dementia Care n = 776	Community-Based Dementia Care n = 831	Usual Care n = 114
Value	9.10 (0.24)	8.98 (0.22)	9.67 (0.65)

Primary outcome: Severity of Dementia-related Behavioral Symptoms

Time frame: 6-month. Mean (Standard Error). Unit: score on a scale

Measure	Health Systems-Based Dementia Care n = 764	Community-Based Dementia Care n = 784	Usual Care n = 107
Value	9.41 (.25)	8.78 (.23)	9.93 (.68)

Primary outcome: Severity of Dementia-related Behavioral Symptoms

Time frame: 12-month. Mean (Standard Error). Unit: score on a scale

Measure	Health Systems-Based Dementia Care n = 665	Community-Based Dementia Care n = 685	Usual Care n = 87
Value	9.58 (.27)	9.14 (.25)	9.95 (.74)

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment through death, withdrawal, or 18 months of follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Systems-Based Dementia Care	528 of 1,016 (52%)	0 of 0	254 of 1,016
Community-Based Dementia Care	533 of 1,016 (52.5%)	0 of 0	223 of 1,016
Usual Care	70 of 144 (48.6%)	0 of 0	37 of 144

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42386685Reuben DB, Stevens AB, Gill TM, Yang M, Volpi E, Lichtenstein ML, Jennings LA, Galloway R, Summapund J, Araujo K, Oyeyemi DM, Cho J, Xu Y, Peduzzi P, Greene EJ. Correlates and predictors of self-efficacy among dementia caregivers: D-CARE findings. Alzheimers Dement. 2026 Jul;22(7):e71636. doi: 10.1002/alz.71636.
Derived from this study: PubMed 41243731Oyeyemi DM, Greene EJ, Xu Y, Lee DR, Samper-Ternent R, Lichtenstein ML, Stevens A, Williamson JD, Karlamangla AS, Saliba D, Reuben DB. Self-efficacy change among diverse family caregivers in dementia care. J Gerontol B Psychol Sci Soc Sci. 2026 Jan 12;81(2):gbaf233. doi: 10.1093/geronb/gbaf233.
Derived from this study: PubMed 40892399Reuben DB, Stevens AB, Gill TM, Williamson J, Volpi E, Lichtenstein ML, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson LC, Yang M, Green AS, Samper-Ternent R, Borek P, Xu Y, Peduzzi P, Greene EJ; D-CARE Study. Patient and Caregiver Outcomes of Health System, Community-Based, and Usual Dementia Care: A Prespecified Analysis of the Dementia Care Study (D-CARE) Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1227-1236. doi: 10.1001/jamainternmed.2025.4247.
Derived from this study: PubMed 39878968Reuben DB, Gill TM, Stevens A, Williamson J, Volpi E, Lichtenstein M, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson L, Yang M, Currie K, Green AS, Godoy S, Abraham S, Reese J, Samper-Ternent R, Hirst RM, Borek P, Charpentier P, Meng C, Dziura J, Xu Y, Skokos EA, He Z, Aiudi S, Peduzzi P, Greene EJ; D-CARE Study. Health System, Community-Based, or Usual Dementia Care for Persons With Dementia and Caregivers: The D-CARE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):950-961. doi: 10.1001/jama.2024.25056.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Reuben, MD principal investigator

University of California, Los Angeles

Thomas Gill, MD principal investigator

Yale University

David Bass, PhD principal investigator

Benjamin Rose Institute on Aging

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health System-based Dementia Care and Community-based Dementia Care in people with Dementia, run by University of California, Los Angeles at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of Dementia-related Behavioral Symptoms (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03786471, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.