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Dementia researchers share recruitment strategies for pragmatic clinical trial

Manuscript highlights methods to successfully enroll diverse participants

2024-02-15
(Press-News.org) WINSTON-SALEM, N.C. – Feb. 15, 2024 – According to the Alzheimer’s Association, more than 6.5 million Americans are living with Alzheimer’s disease, and 1 in 3 older adults will die with the disease or another form of dementia. There’s also a growing need for improved care and support, not only for persons living with dementia but also for their caregivers.

Underrepresented populations are disproportionally more likely to have Alzheimer’s disease compared to other Americans, so there’s an urgent need for clinical trials to be inclusive of diverse groups.

The Dementia Care (D-CARE) Study (2019-2023), which was conducted at four clinical trial sites in the U.S., compared three approaches in dementia care. Despite challenges during the COVID-19 pandemic, D-CARE successfully enrolled 2,176 racially/ethnically diverse persons with Alzheimer’s disease or related dementias and their caregivers.

A paper outlining the study’s recruitment strategies and demographic characteristics was published online today in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

“We hope the lessons learned from D-CARE will guide other investigators in planning their own pragmatic trials of persons living with dementia and their caregivers,” said Mia Yang, M.D., associate professor of gerontology and geriatric medicine at Wake Forest University School of Medicine and corresponding author.

D-CARE, which is the largest dementia care clinical trial to date, was led by the University of California in Los Angeles. Wake Forest University School of Medicine led recruitment at four sites, which also included Baylor Scott & White Health in Temple, Texas; Geisinger Medical Center in Danville, Pennsylvania; and the University of Texas Medical Branch in Galveston, in addition to Wake Forest. Yale Center for Analytical Sciences, Yale School of Public Health served as the data coordinating center.

The study compared the effectiveness of three dementia care interventions:

Health system-based dementia care included care by a nurse practitioner or physician assistant dementia care specialist from the health system plus 24-hour access to an on-call provider in addition to usual care. Community-based dementia care provided a care consultant at a local community agency in addition to usual care. Usual care included access to the Alzheimer’s Association’s 24-hour helpline and local resources. Findings from the trial are expected to be available later this year, but the current paper outlines the following demographics:

80% of the participants with dementia were recruited after the onset of the COVID-19 pandemic. The mean age of patients with dementia was 80.6 years. 58.4% of were women, 8.8% were Hispanic/Latino and 11.9% were Black/African American. The average age of caregivers was 65.2 years and 75.8% were women. 9.4% were Hispanic/Latino and 11.6% were Black/African American. All four clinical trial sites identified eligible participants utilizing their electronic health records (EHRs) and physician/provider referrals as the primary and most effective recruitment strategies. Additional methods included community partner referrals, social media campaigns, local advertising and the adaptation of Spanish-language study materials.

“We also implemented culturally respectful and personalized telephone recruitment to families,” Yang said. “During these pre-screening calls, we provided specific reference to the partnering provider by name.”

Telehealth visits allowed more participants from rural and wider geographic areas to participate.

Yang also said challenges due to the pandemic led to opportunities to find innovative ways to reach study participants. While in-person recruitment efforts were halted, telephone-based recruitment increased, which was more often convenient for patients and their caregivers.

“The study sheds light on the importance of adapting recruitment to meet family needs,” Yang said. “Our diverse participant pool will provide valuable insights on how we can better help patients with dementia and their caregivers.”

END


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[Press-News.org] Dementia researchers share recruitment strategies for pragmatic clinical trial
Manuscript highlights methods to successfully enroll diverse participants