A multi-site randomized clinical trial of socially assistive robots on engaging older adults with cognitive impairment residing in long-term care settings: A protocol paper

Apathy is common in persons with dementias, especially those in long-term care facilities (LTCs). Few pharmacologic options exist; a major strategy is to foster engagement in social, physical, and cognitive activities, but requires extensive personnel time. Non-immersive virtual environments (VE) combined with socially assistive robots (VE-SARs) can support LTC staff.

We are conducting a randomized multi-site clinical trial to compare the effect of usual care (UC) to VE-SAR + UC on reducing apathy (primary outcome) among 188 older adults with cognitive impairment and enhancing executive cognitive function (secondary outcome). Eligibility of state-licensed LTCs include an hour's drive from the principal investigators' offices, activity personnel willing to interact with research staff, certified by the U.S. Centers for Medicare and Medicaid, and physical space for equipment storage and robot set-up. Eligibility for older adults include age ≥ 60 years, LTC residance >3 months, evidence of mild cognitive impairment or dementia, and symptoms of apathy. Older adults randomized to VE-SAR + UC are paired and participate in twice-weekly sessions for 8 weeks. Staff are interviewed using the Apathy Evaluation Scale-Clinician for apathy ratings. Older adults are interviewed on executive cognitive function using the Trail Making Tests A and B and Animal Naming Test. Data are collected at baseline, Week 4, and Week 8. Field notes are taken throughout and sessions are videorecorded. We will use mixed-effects linear modeling for repeated measures to model apathy as a function of fixed-effects of intervention (VE-SAR + UC vs. UC), time, and intervention by time interaction, adjusting for covariates (e.g., baseline cognitive function).