How to PERSEVERE: Study protocol for a national, virtual, randomized controlled trial of a peer mentor-supported educational intervention for family caregivers of people with Lewy body dementia.

BACKGROUND

Family caregivers of people living with Lewy body dementia (PLBD) experience significant strain and adverse health outcomes that consequently affect the health of their loved ones with Lewy Body Dementia (LBD). Effective LBD caregiver interventions are needed. Building on pilot work, our objective is to test the effects of PERSEVERE (Peer Mentor Support and Caregiver Education)- a 12-week peer mentor-supported, LBD-specific educational intervention -on caregiver knowledge, attitudes, strain, and PLBD quality of life and healthcare utilization in a national, virtual, randomized controlled trial.

METHODS

Partnering with LBD caregiver advisors and advocacy organizations, we are recruiting and enrolling 180 seasoned caregivers (having cared for a PLBD with ≥3 years of cognitive symptoms) and 502 novice LBD family caregivers (<3 years of cognitive symptoms). Seasoned caregivers train as Mentors. Novice caregivers are randomized 1:1 in cohorts of 100 to (1) the Mentee group receiving weekly Mentor calls covering a novel LBD curriculum focused on symptom management, future planning, and caregiver support, or (2) the attention-control group receiving pre-existing resources for self-directed learning. Primary outcomes include change from baseline in caregiver knowledge and attitudes at 12 weeks (post-intervention) and caregiver strain at nine months (follow-up). Secondary outcomes include engagement with materials and/or mentor, satisfaction, future interest, and change in PLBD quality of life and PLBD healthcare utilization at nine months.

DISCUSSION: A peer mentor-delivered LBD-focused curriculum may improve caregiver and PLBD outcomes in a cost-effective, scalable manner. PERSEVERE has experienced robust national enrollment and retention within the first 18 months of recruitment, with outcomes forthcoming. Trial Registration https://clinicaltrials.gov/study/NCT06389032, registered on April 24, 2024.