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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Other: Health System-based Dementia Care
* Other: Community-based Dementia Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health Systems-Based Dementia Care<br>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. | Other: Health System-based Dementia Care<br>* Active comparator<br>|
| Active Comparator: Community-Based Dementia Care<br>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. | Other: Community-based Dementia Care<br>* Active comparator<br>|
| Other: Usual Care<br>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. | Other: Usual Care<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months. | 18 months | 
| Caregiver Distress | 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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months. | 18 months | 
| 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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months. | 18 months | 
| 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 outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months. 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, pragmatic clinical trial, effectiveness, cost-effectiveness, Alzheimer's disease