NCT03786471CompletedNot Applicable

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

University of California, Los Angeles4 sites in 1 country2,176 target enrollmentStarted: June 28, 2019Last updated: January 30, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of California, Los Angeles
Enrollment: 2,176
Locations: 4
Primary Endpoint: Caregiver Distress/Strain

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

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.

Arms & Interventions

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.

Intervention: Health System-based Dementia Care (Other)

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.

Intervention: Community-based Dementia Care (Other)

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.

Intervention: Usual Care (Other)

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.