(OT07) Participant Compliance with Scheduled Activities in the Test of Rapamycin in Aging Dogs (TRIAD)

Abstract: Background The Dog Aging Project’s Test of Rapamycin in Aging Dogs (TRIAD) is a randomized clinical trial of low-dose rapamycin with lifespan as the primary endpoint. Hypothesis/Objectives To assess factors that may influence trial protocol compliance. Animals Healthy companion dogs, ≥7 years, 20-55 kg, who have completed the first 12 months of the protocol (N = 120). Methods Completion of trial visits, Monthly at-Home Observation (MAHO) surveys, biannual Quality of Life (QOL) surveys, and adherence to study medication protocol within the first year of enrollment were analyzed. Factors including clinical trial site, distance from site, and owner age group at enrollment were assessed to understand possible relationships with compliance. Dogs were censored at the point of withdrawal (N=2) or death (N=9). Results Mean completion rates of MAHO and QOL surveys were 86.6% (SD 22.5%) and 91.0% (SD 19.4%), respectively. The largest owner age group was 55-64 years (36.7%), with the remainder ranging from 25 to ≥75 years. Median distance from site was 106.65 miles (IQR 51.5-185.5). Completion of 6-month and 12-month clinical site visits were 98.2% and 97.2%, respectively (N = 113, N = 106). Examined factors did not reveal an influence on compliance with study protocol within the first year of enrollment in TRIAD. Conclusions and Clinical Importance Compliance with the TRIAD clinical protocol during the treatment period was very high. Continued study of factors that may influence compliance in the treatment and post-treatment periods will be beneficial to TRIAD and other long-term veterinary clinical trials.