Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,176
- Locations
- 8
- Primary Endpoint
- Caregiver Distress/Strain
Study Overview
Brief Summary
D-CARE: The Dementia Care Study
This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker, nurse, or therapist) who works at a Community-Based Organization (CBO).
The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.
Detailed Description
D-CARE: The Dementia Care Study
Objective
To determine the comparative effectiveness and cost-effectiveness of two evidence-based models of comprehensive dementia care, as well as the effectiveness and cost-effectiveness of both models versus usual care.
Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the patient/caregiver dyad.
Duration: 6.5 years. This includes 34 months for recruitment of study participants, 18 months of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The person with dementia has a diagnosis of dementia established by a physician or other primary care provider
- •The person with dementia has a primary care provider who is willing to partner with the study
- •The person with dementia has a caregiver who speaks English or Spanish, and has a phone
- •Persons living with dementia in assisted living facilities will be eligible if they do not meet any exclusion criteria (however, no more than 25% of participants can be living in assisted living facilities at the time of enrollment. This will be monitored when the first 25% of the sample has been enrolled.)
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms(Average of 3M, 6M, 12M, and 18M least square means)
- Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)(Baseline)
- Severity of Depression in Caregivers(Average of 3M, 6M, 12M, and 18M least square means)
- Severity of Depression in Caregivers (Common Baseline)(Baseline)
- Caregiver Self-Efficacy: 4-item Self-efficacy Scale(Average of 6M and 18M least square means)
- Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)(Baseline)
Investigators
David B. Reuben, MD
Director, Multicampus Program in Geriatric Medicine & Gerontology; Chief, Division of Geriatrics
University of California, Los Angeles