N/A N=2,176 Randomized Double-blind Supportive Care

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

Dementia

Bottom Line

View on ClinicalTrials.gov: NCT03786471 ↗

Enrolled (actual)

2,176

Serious AEs

52.0%

Results posted

Jan 2025

Primary outcome: Primary: Severity of Dementia-related Behavioral Symptoms — 10.32; 9.93; 10.42 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Health System-based Dementia Care (Other); Community-based Dementia Care (Other); Usual Care (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Severity of Dementia-related Behavioral Symptoms (Common Baseline)	10.07	—
PRIMARY Severity of Dementia-related Behavioral Symptoms	9.79; 9.50; 10.12	0.33
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
PRIMARY Caregiver Distress/Strain (Common Baseline)	10.61	—
PRIMARY Caregiver Distress/Strain	10.74; 10.50; 10.60	0.54
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)	12.62	—
SECONDARY Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29; 11.77; 13.10	0.48
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Severity of Depression in Caregivers (Common Baseline)	4.72	—
SECONDARY Severity of Depression in Caregivers	4.70; 4.42; 4.69	0.23
SECONDARY Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.06; 15.22; 14.36	0.62
SECONDARY Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.06; 15.22; 14.36	0.62
SECONDARY Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.06; 15.22; 14.36	0.62
SECONDARY Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)	13.24	—
SECONDARY Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.06; 15.22; 14.36	0.62

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03786471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.