Enrollment is complete for the largest national clinical trial on approaches for dementia care
The Dementia Care Study (D-CARE), a nation-wide clinical trial assessing the effectiveness of different approaches to caring for people with Alzheimer’s disease and other dementias, has reached its recruitment goal by enrolling 2,176 persons living with dementia and their caregivers at four sites: Wake Forest University in North Carolina, Baylor Scott & White Health in Texas, the University of Texas Medical Branch at Galveston, and Geisinger Health System in Pennsylvania. The study, based at UCLA, is supported by researchers at the Benjamin Rose Institute on Aging (BRIA) in Cleveland, the University of Oklahoma, and by teams of local and national patients and stakeholders. Yale University is serving as the Data Coordinating Center.
Funded by the Patient-Centered Outcomes Research Institute (PCORI) and the National Institute on Aging (R01AG061078-01), D-CARE compares the effectiveness of three types of dementia care over 18 months. Participants have been randomly assigned to receive care delivery in one of three ways: by nurse practitioner or physician assistant Dementia Care Specialists within a health care system (based on the UCLA Alzheimer’s and Dementia Care Program), care delivered by a community-based service organization (utilizing Benjamin Rose’s BRI Care Consultation Program), or usual care, including information about how to contact the Alzheimer’s Association Helpline for assistance. Both the UCLA Alzheimer’s and Dementia Care Program and BRI Care Consultation are included in and approved by Best Practice Caregiving (bpc.caregiver.org). The study’s aim is to determine which approach works better to reduce symptoms such as behavioral disturbances and alleviate caregiver strain. Other outcomes include the person with dementia’s quality of life, the ability to reach personal goals, and caregiver self-efficacy, distress, and depressive symptoms. Health care utilization, including long-term nursing home placement and days spent at home, will also be measured.
“The D-CARE study is the largest clinical trial of dementia care conducted to date,” said David B. Reuben, MD, Archstone Professor of Geriatrics at UCLA and Principal Investigator of the study. “The ongoing creativity and perseverance of the clinical trial sites in meeting the challenges of recruitment and delivering the interventions during the relentless COVID-19 pandemic has been amazing,” said Reuben. “Moreover, the study has been successful in recruiting substantial numbers of underrepresented minority and rural participants,” he noted.
Many clinical studies test whether a treatment works under ideal conditions in specialized research centers, but health care is rarely delivered in such idealized situations and settings. Pragmatic clinical studies, such as D-CARE, test a treatment’s effectiveness in “real-life” medical practice situations, such as primary care and specialty outpatient clinics, that include a wider range of study participants, making their findings more generally applicable.
The researchers expect to complete the trial in 2024, with results to be published in 2025.