Trial Design and Oversight
dementia
BROWN
The trial protocol was approved by the Brown University institutional review board and was overseen by a National Institute on Aging–appointed safety officer. The full trial protocol (The pilot study was designed as a multisite, pragmatic, randomized clinical trial to test the feasibility of enrolling people with dementia, randomizing them to 1 of 2 home-delivered meal interventions, monitoring their fidelity to the intervention, linking them to data from the CMS, and analyzing their outcomes. Enrollment began April 7 and ended October 8, 2021. Final, 6-month follow-up observations concluded April 8, 2022. The pilot study included a qualitative substudy in which a subset of participants and a subset of caregivers participated in in-depth telephone interviews. (The approach and results of the substudy are published elsewhere.