Describe a multilevel, community-based participatory process to recruit diverse Lewy Body Dementia (LBD) family caregivers into a nationwide, virtual, randomized controlled trial (RCT, NCT06389032). 

LBD is often a delayed or missed diagnosis and LBD family caregivers face high strain without the support of LBD-specific interventions. Developing LBD caregiver-specific evidence is challenged by under-enrollment and homogeneous cohorts. Identifying LBD family caregivers is challenging, and male, rural, and non-Caucasian LBD caregivers are underrepresented as study participants. We partnered with advocacy organizations and caregiver advisors to design a phased recruitment strategy for an LBD caregiver RCT.

Collaborating with Parkinson’s Foundation, Lewy Body Dementia Association, and LBD caregiver advisors, we will recruit 622 LBD caregivers over two years. Health literacy-friendly study materials were designed with diverse caregiver and care recipient representation. Recruitment began with physician referrals, and local support groups followed by foundation hotline staff training, social media, and clinical trial directory listings.  Recruitment expanded to neurologists at academic medical centers with greater proportions of—or specific programming for—underrepresented groups, independent Parkinson’s organizations, local, regional, and national support groups and newsletters, Parkinson’s-specific exercise and allied health programs, and aging, social services, and neurology conferences. Participants indicate their referral source during screening, with demographics collected upon enrollment.

Through multipronged efforts, 424 individuals have been screened and 240 enrolled in the first 4.5 months of the study. Referral sources are: national organizations (62.2%); support groups (17.2%); word-of-mouth/other caregivers (7.3%); referring providers (6.6%); and clinical trial websites (2.6%). Among enrolled participants, 15.8% are male, 8.4% non-Caucasian, 5.4% Latinx/Hispanic, and 9.4% rural-dwelling.  

Recruiting LBD family caregivers to a large RCT requires broad outreach, including national organizations, social media, providers, and trial directories. Caregiver-driven dissemination highlights the interest in and need for such an intervention, however additional strategies to recruit underrepresented caregivers will be paramount moving forwards.